Prostate Cancer Metastatic
Conditions
Keywords
Prostatic Neoplasms, Cancer of Prostate, Cancer of the Prostate, Neoplasms, Prostate, Prostate Cancer, Prostatic Cancer, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Prostatic Diseases, PSMA, Prostate-specific membrane antigen, Gallium radioisotope 68, 68Ga-PSMA-R2, 68Ga-PSMA ligand
Brief summary
This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
Detailed description
This study consisted of 2 parts. * During the first part (Phase I) of the study, 6 subjects with biochemically recurrent prostate cancer (PCa) received the investigational product (IP) and remained at the site for approximately 6 hours post-administration in order to assess the PK, biodistribution versus time, and dosimetry for critical organs. Subjects received a single dose of 3 MBq/kg, (\>=150 and =\<250 MBq), of 68\^Ga-PSMA-R2 intravenously. Serial blood and urine samples were collected for PK characterization and dosimetry and whole-body PET/CT were acquired at selected time points (0 to 4 hours) to determine organ and tumor absorbed doses. Safety assessments were conducted after IP administration on Day 1, and during follow-up on Days 7 and 28. * In the second part of the study (Phase II), 2 groups of 12 subjects were enrolled (subjects with PCa in biochemical recurrence \[PCa-BR\], and subjects with prostate cancer in the metastatic stage \[mPCa\]). Based on the preliminary data analysis from the Phase I part of the study provided sufficient dosimetry data, all subjects underwent the whole body PET/CT imaging optimized for time (up to 2 time points) according to the data analysis from the Phase I part of the study. This study was comprised of 4 clinical visits and conducted in 3 study periods: screening, administration/imaging, and safety follow-up period.
Interventions
DRUG[68Ga]-PSMA-R2
radio-labelled PSMA ligand
Sponsors
Advanced Accelerator Applications
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Phase I: characterize PK and dosimetry Phase II: diagnostic potential in 2 groups 1. Prostate Cancer in biochemical relapse, and 2. Metastatic Prostate Cancer
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males 18 years or older. 2. Signed and dated written informed consent by the subject prior to any study-specific procedures. 3. Histologically confirmed adenocarcinoma of the prostate, defined as follows: 1. Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions. OR 2. Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least 1 metastatic lymph node, visceral metastasis and/or bone metastasis). 3. At least 2 weeks must have elapsed between last anticancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2. 4. Prior major surgery must be at least 12 weeks prior to study entry. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, with a life expectancy ≥6 months. 6. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening: 1. Hemoglobin (Hb): \>8 g/dL 2. Platelet count of \>50.000/mm3 7. Serum creatinine \<1.5\*upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) \>50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 8. For male subjects with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.
Exclusion criteria
1. Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histologies different than adenocarcinoma. 2. Administered a radioisotope =\<10 physical half-lives prior to the day of PET/CT. 3. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or need of indwelling/condom catheters. 4. Uncontrolled pain or incompatibility that results in subject's lack of compliance with imaging procedures. 5. Other known coexisting malignancies except non-melanoma skin or low grade superficial bladder cancer unless definitively treated and proven no evidence of recurrence for 5 years. 6. Subject with known incompatibility to CT scans. 7. Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol, or active infection including human immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for chronic conditions was not required. 8. Subjects who have received any investigational agent within the last 28 days were excluded from participation in this study. 9. Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Studies. 10. Known allergy, hypersensitivity, or intolerance to the IP or its excipients. 11. Subject unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | dosing through 28 days post-dose | Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Urinary Excretion of [68Ga]-PSMA-R2 | 0 to 6 hours post-dose | Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics. |
| Phase I: Half-life of 68Ga-PSMA-R2 in Blood | 0 to 6 hours post-dose | Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\^1/2) for the analyte in blood was summarized with descriptive statistics. |
| Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. |
| Phase I: Residence Times in Normal Organs | 68Ga-PSMA-R2 PET imaging acquired at Day 1 | Residence times of radiation in normal organs were summarized with descriptive statistics. |
| Phase I: Absorbed Dose of 68Ga-PSMA-R2 | 68Ga-PSMA-R2 PET imaging acquired at Day 1 | Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics. |
| Phase I: Whole-body Dose of 68Ga-PSMA-R2 | 68Ga-PSMA-R2 PET imaging acquired at Day 1 | The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. |
| Phase I: Effective Dose of 68Ga-PSMA-R2 | 68Ga-PSMA-R2 PET imaging acquired at Day 1 | The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. |
| Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. |
| Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows: * Positive percent agreement: a/(a+c) × 100 * Negative percent agreement: d/(b+d) × 100 * Overall percent agreement: (a+d)/(a+b+c+d) × 100 Where: * a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan * b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan * c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan * d = number of subjects with no lesions detected by conventional scan or PET scan. |
| Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection) | The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics. |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)
Participants by arm
| Arm | Count |
|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. | 6 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. | 12 |
| Metastatic Prostate Cancer (mPCa) (Phase II) All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\]. | 12 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | family issue (child custody) | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Total | Metastatic Prostate Cancer (mPCa) (Phase II) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) |
|---|---|---|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 7.91 | 68.3 Years STANDARD_DEVIATION 8.13 | 68.6 Years STANDARD_DEVIATION 10 | 69.1 Years STANDARD_DEVIATION 6.53 |
| Baseline Height | 183.00 centimeter (cm) STANDARD_DEVIATION 5.03 | 178.65 centimeter (cm) STANDARD_DEVIATION 6.281 | 177.03 centimeter (cm) STANDARD_DEVIATION 5.927 | 177.96 centimeter (cm) STANDARD_DEVIATION 6.596 |
| Baseline Weight | 91.48 kilogram (kg) STANDARD_DEVIATION 18.091 | 90.29 kilogram (kg) STANDARD_DEVIATION 15.89 | 93.20 kilogram (kg) STANDARD_DEVIATION 11.402 | 87.03 kilogram (kg) STANDARD_DEVIATION 18.838 |
| ECOG Performance Status Grade 0 | 6 Participants | 21 Participants | 6 Participants | 9 Participants |
| ECOG Performance Status > = Grade 1 | 0 Participants | 9 Participants | 6 Participants | 3 Participants |
| Number of patients by castration type Not Applicable | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Number of patients by castration type Pharmacological | 1 Participants | 15 Participants | 11 Participants | 3 Participants |
| Number of patients by castration type Surgery | 0 Participants | 14 Participants | 4 Participants | 10 Participants |
| Number of patients by Primary and Secondary Gleason score Primary Gleason score=3 &Secondary Gleason score=3 | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Number of patients by Primary and Secondary Gleason score Primary Gleason score=3 &Secondary Gleason score=4 | 2 Participants | 6 Participants | 0 Participants | 4 Participants |
| Number of patients by Primary and Secondary Gleason score Primary Gleason score=4 &Secondary Gleason score=3 | 2 Participants | 9 Participants | 3 Participants | 4 Participants |
| Number of patients by Primary and Secondary Gleason score Primary Gleason score=4 &Secondary Gleason score=4 | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Number of patients by Primary and Secondary Gleason score Primary Gleason score=4 &Secondary Gleason score=5 | 2 Participants | 7 Participants | 4 Participants | 1 Participants |
| Number of patients by Total Gleason score (>=6) 10 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of patients by Total Gleason score (>=6) 6 | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Number of patients by Total Gleason score (>=6) 7 | 4 Participants | 15 Participants | 3 Participants | 8 Participants |
| Number of patients by Total Gleason score (>=6) 8 | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Number of patients by Total Gleason score (>=6) 9 | 2 Participants | 7 Participants | 4 Participants | 1 Participants |
| Prostate-specific antigen (PSA) levels | 1.68 ng/mL STANDARD_DEVIATION 1.329 | 17.25 ng/mL STANDARD_DEVIATION 44.861 | 38.56 ng/mL STANDARD_DEVIATION 66.603 | 3.72 ng/mL STANDARD_DEVIATION 6.461 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 27 Participants | 11 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 30 Participants | 12 Participants | 12 Participants |
| Time since disease progression | 34.7 Months STANDARD_DEVIATION 33.02 | 5.8 Months STANDARD_DEVIATION 16.01 | 0.8 Months STANDARD_DEVIATION 0.65 | 1.2 Months STANDARD_DEVIATION 1.55 |
| Time since first metastasis | 79.2 Months STANDARD_DEVIATION 46.44 | 88.8 Months STANDARD_DEVIATION 73.41 | 96.1 Months STANDARD_DEVIATION 84.8 | 86.8 Months STANDARD_DEVIATION 78.07 |
| Time since first prostate cancer diagnosis | 79.2 Months STANDARD_DEVIATION 46.44 | 88.8 Months STANDARD_DEVIATION 73.41 | 96.1 Months STANDARD_DEVIATION 84.8 | 86.8 Months STANDARD_DEVIATION 78.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 1 / 6 | 4 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 6 | 1 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time frame: dosing through 28 days post-dose
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Number of Participants With Treatment Emergent Adverse Events | Serious TEAEs | 0 Participants |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Number of Participants With Treatment Emergent Adverse Events | Deaths Due to AEs | 0 Participants |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Serious TEAEs | 1 Participants |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 4 Participants |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Deaths Due to AEs | 0 Participants |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 2 Participants |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Deaths Due to AEs | 0 Participants |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Number of Participants With Treatment Emergent Adverse Events | Serious TEAEs | 0 Participants |
Secondary
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET (positive) | 22 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | Conventional (postive) | 8 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | Difference = PET(+) - Conventional(+) | 14 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET(+) and detected by conventional scan | 7 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Bone,Cervical Spine | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Bone,Lumbar Spine | 3 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Bone,Thoracic Spine | 3 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Pelvic Bone | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Pelvis | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Rib(s),L. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/detected by CT:Rib(s),R. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET(+) and not detected by conventional scan | 21 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Abdominal Wall | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Bone,Lumbar Spine | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Bone,Other | 5 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Bone,Thoracic Spine | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Common Iliac | 9 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,External | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Inguinal,L. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Inguinal,R. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Para-Aortic | 6 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Retrocrural | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Retroperitoneal | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Lymph Node,Supraclavicular,L | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Other,Extranodal | 3 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Other,Nodal | 3 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Pelvic Bone | 6 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Rib(s),L. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Rib(s),R. | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | PET+/undetected by CT:Urethra | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | Conventional (+) and not detected by PET scan | 7 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Bone,Lumbar Spine | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Bone,Other | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Bone,Thoracic Spine | 5 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Lymph Node,Pelvic | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Pelvic Bone | 6 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Rib(s),L. | 2 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Rib(s),R. | 1 Positive Lesion |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | CT+/undetected by PET:Skull | 1 Positive Lesion |
Secondary
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows: * Positive percent agreement: a/(a+c) × 100 * Negative percent agreement: d/(b+d) × 100 * Overall percent agreement: (a+d)/(a+b+c+d) × 100 Where: * a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan * b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan * c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan * d = number of subjects with no lesions detected by conventional scan or PET scan.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Positive percent agreement | 0.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Negative percent agreement | 66.7 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Overall percent agreement | 66.7 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Positive percent agreement | 0.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Negative percent agreement | 33.3 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Overall percent agreement | 33.3 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Overall percent agreement | 5.49 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Positive percent agreement | 0.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Positive percent agreement | 0.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Negative percent agreement | 25.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Negative percent agreement | 25.0 Percent Agreement |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Overall percent agreement | 25.0 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Negative percent agreement | 0.0 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Overall percent agreement | 58.3 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Overall percent agreement | 75.0 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Positive percent agreement | 87.5 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(1hr): Positive percent agreement | 87.5 Percent Agreement |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | PET(2hr): Negative percent agreement | 50.0 Percent Agreement |
Secondary
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Urinary Bladder | 0.120317 mGy/MBq | Standard Deviation 0.0517023 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Brain | 0.002563 mGy/MBq | Standard Deviation 0.000336 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Heart | 0.018417 mGy/MBq | Standard Deviation 0.0020094 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Kidney | 0.060683 mGy/MBq | Standard Deviation 0.0190588 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Lacrimal Gland | 0.008065 mGy/MBq | Standard Deviation 0.0015741 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Liver | 0.017417 mGy/MBq | Standard Deviation 0.0029976 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Lungs | 0.007967 mGy/MBq | Standard Deviation 0.0007718 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Red Marrow | 0.010700 mGy/MBq | Standard Deviation 0.000228 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Salivary Gland | 0.015600 mGy/MBq | Standard Deviation 0.0032012 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Spleen | 0.017333 mGy/MBq | Standard Deviation 0.0037109 |
Secondary
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)
Population: Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@20-30 minutes post-injection | 0.002196 mSv/MBq | Standard Deviation 0.0009359 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@1 hour post-injection | 0.001913 mSv/MBq | Standard Deviation 0.0003011 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@2 hours post-injection | 0.001310 mSv/MBq | Standard Deviation 0.0005902 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@3-4 hours post-injection | 0.001279 mSv/MBq | Standard Deviation 0.0007786 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@20-30 minutes post-injection | 0.009010 mSv/MBq | Standard Deviation 0.0014472 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@1 hour post-injection | 0.006371 mSv/MBq | Standard Deviation 0.001226 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@2 hours post-injection | 0.004330 mSv/MBq | Standard Deviation 0.0014781 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@3-4 hours post-injection | 0.003209 mSv/MBq | Standard Deviation 0.0014961 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@20-30 minutes post-injection | 0.033219 mSv/MBq | Standard Deviation 0.0140235 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@1 hour post-injection | 0.022069 mSv/MBq | Standard Deviation 0.0090106 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@2 hours post-injection | 0.018424 mSv/MBq | Standard Deviation 0.0068331 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@3-4 hours post-injection | 0.015772 mSv/MBq | Standard Deviation 0.0069341 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@20-30 minutes post-injection | 0.000016 mSv/MBq | Standard Deviation 0.0000023 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@1 hour post-injection | 0.000016 mSv/MBq | Standard Deviation 0.0000051 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@2 hours post-injection | 0.000015 mSv/MBq | Standard Deviation 0.0000045 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@3-4 hours post-injection | 0.000014 mSv/MBq | Standard Deviation 0.0000074 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@20-30 minutes post-injection | 0.040546 mSv/MBq | Standard Deviation 0.0098781 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@1 hour post-injection | 0.030958 mSv/MBq | Standard Deviation 0.0073605 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@2 hours post-injection | 0.023145 mSv/MBq | Standard Deviation 0.0083627 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@3-4 hours post-injection | 0.018128 mSv/MBq | Standard Deviation 0.0081345 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@20-30 minutes post-injection | 0.010066 mSv/MBq | Standard Deviation 0.001728 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@1 hour post-injection | 0.007535 mSv/MBq | Standard Deviation 0.0013048 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@2 hours post-injection | 0.005023 mSv/MBq | Standard Deviation 0.0015987 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@3-4 hours post-injection | 0.003601 mSv/MBq | Standard Deviation 0.0016623 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@20-30 minutes post-injection | 0.002001 mSv/MBq | Standard Deviation 0.0004118 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@1 hour post-injection | 0.001585 mSv/MBq | Standard Deviation 0.0004877 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@2 hours post-injection | 0.001282 mSv/MBq | Standard Deviation 0.0006661 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@3-4 hours post-injection | 0.001032 mSv/MBq | Standard Deviation 0.0005455 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@20-30 minutes post-injection | 0.003712 mSv/MBq | Standard Deviation 0.0010597 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@1 hour post-injection | 0.002645 mSv/MBq | Standard Deviation 0.0008966 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@2 hours post-injection | 0.001724 mSv/MBq | Standard Deviation 0.0007601 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@3-4 hours post-injection | 0.001264 mSv/MBq | Standard Deviation 0.0006056 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@20-30 minutes post-injection | 0.000378 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@1 hour post-injection | 0.000266 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@2 hours post-injection | 0.000201 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@3-4 hours post-injection | 0.000128 mSv/MBq | — |
Secondary
Phase I: Effective Dose of 68Ga-PSMA-R2
The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Effective Dose of 68Ga-PSMA-R2 | 0.014583 mSv/MBq | Standard Deviation 0.0019343 |
Secondary
Phase I: Half-life of 68Ga-PSMA-R2 in Blood
Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\^1/2) for the analyte in blood was summarized with descriptive statistics.
Time frame: 0 to 6 hours post-dose
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Half-life of 68Ga-PSMA-R2 in Blood | 2.83 Hour | Standard Deviation 0.868 |
Secondary
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)
Population: Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@20-30 minutes post-injection | 0.001686 mSv/MBq | Standard Deviation 0.0007242 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@1 hour post-injection | 0.001046 mSv/MBq | Standard Deviation 0.0000814 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@2 hours post-injection | 0.000423 mSv/MBq | Standard Deviation 0.000163 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Brain@3-4 hours post-injection | 0.000222 mSv/MBq | Standard Deviation 0.0000924 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@20-30 minutes post-injection | 0.006914 mSv/MBq | Standard Deviation 0.0011156 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@1 hour post-injection | 0.003484 mSv/MBq | Standard Deviation 0.0004766 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@2 hours post-injection | 0.001332 mSv/MBq | Standard Deviation 0.0002056 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Heart Wall@3-4 hours post-injection | 0.000542 mSv/MBq | Standard Deviation 0.0001255 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@20-30 minutes post-injection | 0.025506 mSv/MBq | Standard Deviation 0.0107777 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@1 hour post-injection | 0.012059 mSv/MBq | Standard Deviation 0.0043426 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@2 hours post-injection | 0.005825 mSv/MBq | Standard Deviation 0.0015596 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Kidney@3-4 hours post-injection | 0.002766 mSv/MBq | Standard Deviation 0.0006581 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@20-30 minutes post-injection | 0.000012 mSv/MBq | Standard Deviation 0.0000019 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@1 hour post-injection | 0.000009 mSv/MBq | Standard Deviation 0.0000022 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@2 hours post-injection | 0.000005 mSv/MBq | Standard Deviation 0.0000011 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lacrimal Gland@3-4 hours post-injection | 0.000002 mSv/MBq | Standard Deviation 8e-7 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@20-30 minutes post-injection | 0.031128 mSv/MBq | Standard Deviation 0.0076342 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@1 hour post-injection | 0.016949 mSv/MBq | Standard Deviation 0.0032692 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@2 hours post-injection | 0.007172 mSv/MBq | Standard Deviation 0.0014994 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Liver@3-4 hours post-injection | 0.003087 mSv/MBq | Standard Deviation 0.0006828 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@20-30 minutes post-injection | 0.007729 mSv/MBq | Standard Deviation 0.0013599 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@1 hour post-injection | 0.004149 mSv/MBq | Standard Deviation 0.000666 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@2 hours post-injection | 0.001573 mSv/MBq | Standard Deviation 0.0002652 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Lungs@3-4 hours post-injection | 0.000631 mSv/MBq | Standard Deviation 0.0001601 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@20-30 minutes post-injection | 0.001536 mSv/MBq | Standard Deviation 0.0003192 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@1 hour post-injection | 0.000859 mSv/MBq | Standard Deviation 0.0002093 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@2 hours post-injection | 0.000386 mSv/MBq | Standard Deviation 0.0001469 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Salivary Gland@3-4 hours post-injection | 0.000173 mSv/MBq | Standard Deviation 0.000055 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@20-30 minutes post-injection | 0.002849 mSv/MBq | Standard Deviation 0.000814 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@1 hour post-injection | 0.001444 mSv/MBq | Standard Deviation 0.0004213 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@2 hours post-injection | 0.000536 mSv/MBq | Standard Deviation 0.000164 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Spleen@3-4 hours post-injection | 0.000217 mSv/MBq | Standard Deviation 0.0000567 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@20-30 minutes post-injection | 0.000289 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@1 hour post-injection | 0.000136 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@2 hours post-injection | 0.000057 mSv/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | Thyroid@3-4 hours post-injection | 0.000020 mSv/MBq | — |
Secondary
Phase I: Residence Times in Normal Organs
Residence times of radiation in normal organs were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Population: Full Analysis Set (FAS). For each parameter, only participants with a value are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Brain | 0.002895 MBq-hr/MBq | Standard Deviation 0.0009849 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Heart | 0.010459 MBq-hr/MBq | Standard Deviation 0.0014152 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Kidney | 0.039360 MBq-hr/MBq | Standard Deviation 0.01335 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Lacrimal Gland | 0.000027 MBq-hr/MBq | Standard Deviation 0.0000052 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Liver | 0.050735 MBq-hr/MBq | Standard Deviation 0.0103951 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Lungs | 0.012084 MBq-hr/MBq | Standard Deviation 0.0019321 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Salivary Gland | 0.002594 MBq-hr/MBq | Standard Deviation 0.0006622 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Spleen | 0.004291 MBq-hr/MBq | Standard Deviation 0.0012416 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Thyroid | 0.000424 MBq-hr/MBq | — |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Urinary Bladder | 0.092947 MBq-hr/MBq | Standard Deviation 0.0453608 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Residence Times in Normal Organs | Remainder | 1.417135 MBq-hr/MBq | Standard Deviation 0.0582923 |
Secondary
Phase I: Urinary Excretion of [68Ga]-PSMA-R2
Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.
Time frame: 0 to 6 hours post-dose
Population: Full Analysis Set (FAS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Urinary Excretion of [68Ga]-PSMA-R2 | 5870 mL/hr | Standard Deviation 1820 |
Secondary
Phase I: Whole-body Dose of 68Ga-PSMA-R2
The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Phase I: Whole-body Dose of 68Ga-PSMA-R2 | 0.013800 mGy/MBq | Standard Deviation 0.0000632 |
Secondary
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (1hr): SUVmax (lesion) | 7.087 Standard Uptake Value (SUV) | Standard Deviation 4.9133 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (1hr): SUVmean (background) | 0.689 Standard Uptake Value (SUV) | Standard Deviation 0.1955 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (2hr): SUVmax (lesion) | 7.647 Standard Uptake Value (SUV) | Standard Deviation 5.3409 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (2hr): SUVmean (background) | 0.541 Standard Uptake Value (SUV) | Standard Deviation 0.2234 |
Secondary
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmax (lesion) | 4.493 Standard Uptake Value (SUV) | Standard Deviation 1.406 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmean (background) | 0.980 Standard Uptake Value (SUV) | Standard Deviation 0.0283 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmax (lesion) | 3.767 Standard Uptake Value (SUV) | Standard Deviation 1.1493 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmean (background) | 0.630 Standard Uptake Value (SUV) | Standard Deviation 0.3145 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmean (background) | 0.651 Standard Uptake Value (SUV) | Standard Deviation 0.2817 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmax (lesion) | 4.421 Standard Uptake Value (SUV) | Standard Deviation 1.4512 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmax (lesion) | 5.098 Standard Uptake Value (SUV) | Standard Deviation 1.8597 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmean (background) | 0.643 Standard Uptake Value (SUV) | Standard Deviation 0.2318 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmean (background) | 0.581 Standard Uptake Value (SUV) | Standard Deviation 0.2119 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmean (background) | 0.723 Standard Uptake Value (SUV) | Standard Deviation 0.302 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): SUVmax (lesion) | 6.566 Standard Uptake Value (SUV) | Standard Deviation 4.5956 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): SUVmax (lesion) | 6.578 Standard Uptake Value (SUV) | Standard Deviation 5.8224 |
Secondary
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmax (lesion) | 4.493 Standard Uptake Value (SUV) | Standard Deviation 1.406 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmean (background) | 0.980 Standard Uptake Value (SUV) | Standard Deviation 0.0283 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmax (lesion) | 3.767 Standard Uptake Value (SUV) | Standard Deviation 1.1493 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmean (background) | 0.630 Standard Uptake Value (SUV) | Standard Deviation 0.3145 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmean (background) | 0.651 Standard Uptake Value (SUV) | Standard Deviation 0.2817 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmax (lesion) | 4.421 Standard Uptake Value (SUV) | Standard Deviation 1.4512 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmax (lesion) | 5.098 Standard Uptake Value (SUV) | Standard Deviation 1.8597 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmean (background) | 0.643 Standard Uptake Value (SUV) | Standard Deviation 0.2318 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmean (background) | 0.550 Standard Uptake Value (SUV) | Standard Deviation 0.1948 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmean (background) | 0.750 Standard Uptake Value (SUV) | Standard Deviation 0.3002 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (2hr): SUVmax (lesion) | 6.846 Standard Uptake Value (SUV) | Standard Deviation 4.7745 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | PET (1hr): SUVmax (lesion) | 6.725 Standard Uptake Value (SUV) | Standard Deviation 5.5327 |
Secondary
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (1hr): TBR | 11.573 Ratio | Standard Deviation 10.2632 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | PET (2hr): TBR | 14.880 Ratio | Standard Deviation 10.1991 |
Secondary
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): TBR | 4.520 Ratio | Standard Deviation 1.3558 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): TBR | 5.694 Ratio | Standard Deviation 1.7104 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): TBR | 7.464 Ratio | Standard Deviation 3.0364 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): TBR | 7.780 Ratio | Standard Deviation 3.6034 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (1hr): TBR | 10.965 Ratio | Standard Deviation 10.9067 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | PET (2hr): TBR | 11.788 Ratio | Standard Deviation 8.6914 |
Secondary
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (1hr): TBR | 4.520 Ratio | Standard Deviation 1.3558 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (2hr): TBR | 5.694 Ratio | Standard Deviation 1.7104 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (1hr): TBR | 7.464 Ratio | Standard Deviation 3.0364 |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (2hr): TBR | 7.780 Ratio | Standard Deviation 3.6034 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (1hr): TBR | 11.141 Ratio | Standard Deviation 10.6283 |
| Metastatic Prostate Cancer (mPCa) (Phase II) | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | PET (2hr): TBR | 12.588 Ratio | Standard Deviation 9.1146 |