Metastatic Castration Resistant Prostate Cancer
Conditions
Brief summary
This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.
Detailed description
Upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. Radioligand therapy (RLT) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (GBq) (+/- 10%) or 7.4 GBq (+/- 10%) 177Lu-PSMA-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray (Gy). All doses after labeling were presented in buffered solution for i.v. injection. In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mCRPC) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. Each patient underwent a screening visit within 14 days prior to receiving study drug. Treatment was continued until either of the following conditions applied: * Prostate-specific antigen (PSA)/radiographic progression at \>= 12 weeks * Completion of four RLT cycles * 23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry * Patient withdrawal (e.g. appearance of intolerable adverse events).
Interventions
DRUG177Lu-PSMA-617
Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
Sponsors
Endocyte
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Prostate cancer proven by histopathology 2. Unresectable metastases 3. Progressive disease, both docetaxel naive and docetaxel treated. 4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT) 5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy 6. ECOG 0-2 7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles 8. Signing of the Informed Consent Form 9. Patients enrolling in this trail should have received either Enzalutamide or Abiraterone
Exclusion criteria
1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy. 2. Glomerular Filtration Rate (GFR) \<40 ml/min 3. Serum creatinine \> 1.5 ULN 4. AST and ALT\>5xULN 5. Urinary tract obstruction or marked hydronephrosis 6. Diffuse bone marrow involvement confirmed by super-scans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | From first dosing (Day 0) 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, up to 24 months | Treatment-emergent adverse events (TEAEs) were collected from first dosing 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. |
| Number of Participants Achieving PSA Response at Week 12 | Week 12 | PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from Baseline at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA Progression and Death Events | Date of randomization to the date of first documented PSA progression or death, whichever occurs first, reported between day of first patient randomized up to 24 months after the first treatment | PSA progression was defined as: 1. For patients with PSA decline: PSA progression was defined as the date that a \>= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks were ignored (PCWG3 Guidance), 2. For patients without PSA decline: PSA progression was defined as a \>= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment. |
| RECIST 1.1 Overall Response by Follow-up Assessment Visit | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. | For each follow-up imaging assessment by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI: the number of participants with an overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. |
| RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. | The proportion of participants with an overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) was reported using investigator assessments per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI. The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. |
| Percent Change in PSA From Baseline to Week 12 | Week 12 | Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments. |
| Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Baseline, Month 3, Month 6, Follow-up Month 3 | The Expanded Prostate Cancer Index-Composite (EPIC) is a well-established patient-reported outcome (PRO) questionnaire developed to monitor health-related quality of life outcomes among prostate cancer. The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. |
| Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline, Treatment Visit 1, Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Follow-up Month 3, Follow-up Month 12, Follow-up Month 15 | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = dead. |
| Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening, Week 8, Week 10, Week 16, Week 18, Week 22, Week 24, Follow-up Week 4, Follow-up Week 6, Follow-up Week 8 | Investigator's assessed bone metastases using the Prostate Cancer Working Group 3 (PCWG3) criteria; new lesions had to be confirmed on a second scan (2+2 rule). The investigator documented their clinical impression of each PCWG3 assessment as Improved, Stable or Progression. The number of participants with a clinical impression of Improved, Stable or Progression according to PCWG3 using investigators assessments was reported by visit. |
| Maximum Percent Change in PSA Response | Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment | Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 2 centers in the USA
Participants by arm
| Arm | Count |
|---|---|
| 177Lu-PSMA-617 (6.0 GBq) Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry | 28 |
| 177Lu-PSMA-617 (7.4 GBq) Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry | 43 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason | 1 | 1 |
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Any occurrence of conditions which prevented the patient's participation in the study. | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | 177Lu-PSMA-617 (6.0 GBq) | 177Lu-PSMA-617 (7.4 GBq) | Total |
|---|---|---|---|
| Age, Continuous | 72.1 Years STANDARD_DEVIATION 8.39 | 69.1 Years STANDARD_DEVIATION 8.62 | 70.3 Years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 41 Participants | 67 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 28 Participants | 43 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 23 | 3 / 41 |
| other Total, other adverse events | 22 / 23 | 38 / 41 |
| serious Total, serious adverse events | 4 / 23 | 8 / 41 |
Outcome results
Primary
Number of Participants Achieving PSA Response at Week 12
PSA response was defined as the proportion of patients who had a \>= 50% decrease in PSA from Baseline at Week 12.
Time frame: Week 12
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (Increase from Baseline) | 3 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (< 50% decline) | 5 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (>= 50% decline) | 6 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (Increase from Baseline) | 11 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (< 50% decline) | 8 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants Achieving PSA Response at Week 12 | PSA Response (>= 50% decline) | 6 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were collected from first dosing 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: From first dosing (Day 0) 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, up to 24 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | Drug-related TEAEs | 20 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to reduction of Lu-PSMA-617 | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | Serious TEAEs | 4 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to discontinuation of Lu-PSMA-617 | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | Serious drug-related TEAEs | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to death | 2 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 22 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to death | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | Treatment-Emergent Adverse Events (TEAEs) | 39 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | Serious TEAEs | 8 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | Drug-related TEAEs | 37 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | Serious drug-related TEAEs | 4 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to reduction of Lu-PSMA-617 | 2 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Number of Participants With Treatment Emergent Adverse Events | TEAEs leading to discontinuation of Lu-PSMA-617 | 1 Participants |
Secondary
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = dead.
Time frame: Baseline, Treatment Visit 1, Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Follow-up Month 3, Follow-up Month 12, Follow-up Month 15
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline | 0.9 Scores on a scale | Standard Deviation 0.81 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 1 | -0.2 Scores on a scale | Standard Deviation 0.6 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 2 | -0.3 Scores on a scale | Standard Deviation 0.6 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 3 | -0.2 Scores on a scale | Standard Deviation 0.73 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 4 | -0.1 Scores on a scale | Standard Deviation 0.93 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Follow-up Month 3 | 0.0 Scores on a scale | — |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Follow-up Month 15 | 0.0 Scores on a scale | — |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 3 | -0.2 Scores on a scale | Standard Deviation 0.5 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline | 0.9 Scores on a scale | Standard Deviation 0.61 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Follow-up Month 12 | -1.0 Scores on a scale | — |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 1 | 0.0 Scores on a scale | Standard Deviation 0.54 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 4 | -0.3 Scores on a scale | Standard Deviation 0.48 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Change from BL@Treatment Visit 2 | -0.1 Scores on a scale | Standard Deviation 0.63 |
Secondary
Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
The Expanded Prostate Cancer Index-Composite (EPIC) is a well-established patient-reported outcome (PRO) questionnaire developed to monitor health-related quality of life outcomes among prostate cancer. The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life.
Time frame: Baseline, Month 3, Month 6, Follow-up Month 3
Population: ITT Population. For each domain, only participants with a value at both baseline and post baseline were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Baseline) | 83.2 Unit on a scale | Standard Deviation 20.73 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Baseline) | 8.8 Unit on a scale | Standard Deviation 9.74 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Change from BL@Month 3) | 4.9 Unit on a scale | Standard Deviation 12.57 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Change from BL@Month 3) | -4.4 Unit on a scale | Standard Deviation 11.68 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Baseline) | 90.8 Unit on a scale | Standard Deviation 14.6 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Change from BL@Month 6) | -4.7 Unit on a scale | Standard Deviation 5.02 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Change from BL@Month 3) | 17.9 Unit on a scale | Standard Deviation 25.37 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Change from BL@Month 3) | -1.0 Unit on a scale | Standard Deviation 8.55 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Baseline) | 77.0 Unit on a scale | Standard Deviation 18.19 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Change from BL@Month 6) | 11.1 Unit on a scale | Standard Deviation 19.2 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Change from BL@Month 3) | 4.4 Unit on a scale | Standard Deviation 16.35 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Change from BL@Month 6) | -4.2 Unit on a scale | Standard Deviation 8.33 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Change from BL@Month 6) | 1.7 Unit on a scale | Standard Deviation 28.87 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Change from BL@Month 6) | 2.1 Unit on a scale | Standard Deviation 9.55 |
| 177Lu-PSMA-617 (6.0 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Baseline) | 78.3 Unit on a scale | Standard Deviation 26.87 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Change from BL@Month 6) | 7.3 Unit on a scale | Standard Deviation 5.82 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Change from BL@Follow-up Month 3) | 4.6 Unit on a scale | Standard Deviation 4.85 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Baseline) | 73.6 Unit on a scale | Standard Deviation 16.13 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Change from BL@Month 3) | 10.4 Unit on a scale | Standard Deviation 24.62 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Change from BL@Month 6) | 10.0 Unit on a scale | Standard Deviation 10 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Hormonal (Change from BL@Follow-up Month 3) | 8.3 Unit on a scale | Standard Deviation 7.64 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Baseline) | 77.4 Unit on a scale | Standard Deviation 24.64 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Change from BL@Month 3) | 9.7 Unit on a scale | Standard Deviation 20.88 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Change from BL@Month 6) | -6.3 Unit on a scale | Standard Deviation 14.66 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Incontinence (Change from BL@Follow-up Month 3) | -2.1 Unit on a scale | Standard Deviation 9.55 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Baseline) | 84.8 Unit on a scale | Standard Deviation 19.13 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Change from BL@Month 3) | -1.4 Unit on a scale | Standard Deviation 4.17 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Change from BL@Month 6) | 6.3 Unit on a scale | Standard Deviation 8.84 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Urinary Irritative/Obstructive (Change from BL@Follow-up Month 3) | 8.3 Unit on a scale | Standard Deviation 9.55 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Baseline) | 88.4 Unit on a scale | Standard Deviation 14.77 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Change from BL@Month 3) | 4.0 Unit on a scale | Standard Deviation 18.57 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Change from BL@Month 6) | 4.9 Unit on a scale | Standard Deviation 16.75 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Bowel (Change from BL@Follow-up Month 3) | -8.3 Unit on a scale | Standard Deviation 18.16 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Baseline) | 11.7 Unit on a scale | Standard Deviation 19.66 |
| 177Lu-PSMA-617 (7.4 GBq) | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Sexual (Change from BL@Month 3) | 7.8 Unit on a scale | Standard Deviation 15.76 |
Secondary
Maximum Percent Change in PSA Response
Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups.
Time frame: Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Maximum Percent Change in PSA Response | -3.63 PSA percent change | Standard Deviation 95.394 |
| 177Lu-PSMA-617 (7.4 GBq) | Maximum Percent Change in PSA Response | 8.75 PSA percent change | Standard Deviation 132.954 |
Secondary
Percent Change in PSA From Baseline to Week 12
Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments.
Time frame: Week 12
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Percent Change in PSA From Baseline to Week 12 | -22.54 Percent change in PSA | Standard Deviation 75.513 |
| 177Lu-PSMA-617 (7.4 GBq) | Percent Change in PSA From Baseline to Week 12 | 92.15 Percent change in PSA | Standard Deviation 301.932 |
Secondary
Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit
Investigator's assessed bone metastases using the Prostate Cancer Working Group 3 (PCWG3) criteria; new lesions had to be confirmed on a second scan (2+2 rule). The investigator documented their clinical impression of each PCWG3 assessment as Improved, Stable or Progression. The number of participants with a clinical impression of Improved, Stable or Progression according to PCWG3 using investigators assessments was reported by visit.
Time frame: Screening, Week 8, Week 10, Week 16, Week 18, Week 22, Week 24, Follow-up Week 4, Follow-up Week 6, Follow-up Week 8
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Stable | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Stable | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Stable | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Stable | 2 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Improved | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Stable | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Stable | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Stable | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Progression | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Stable | 2 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Improved | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Progression | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Stable | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Stable | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Progression | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Stable | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Screening | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Improved | 3 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Stable | 2 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 8 | Progression | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Improved | 3 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Stable | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 10 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Improved | 2 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Stable | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 16 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Stable | 3 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 18 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Stable | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 22 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Stable | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Week 24 | Progression | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Stable | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 4 | Progression | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Stable | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 6 | Progression | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Improved | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Follow-up Week 8 | Stable | 0 Participants |
Secondary
PSA Progression and Death Events
PSA progression was defined as: 1. For patients with PSA decline: PSA progression was defined as the date that a \>= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks were ignored (PCWG3 Guidance), 2. For patients without PSA decline: PSA progression was defined as a \>= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment.
Time frame: Date of randomization to the date of first documented PSA progression or death, whichever occurs first, reported between day of first patient randomized up to 24 months after the first treatment
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | PSA Progression and Death Events | Deaths without PSA progression | 2 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | PSA Progression and Death Events | Participants with PSA progression, but who did not die | 11 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | PSA Progression and Death Events | Deaths without PSA progression | 2 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | PSA Progression and Death Events | Participants with PSA progression, but who did not die | 17 Participants |
Secondary
RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit
The proportion of participants with an overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) was reported using investigator assessments per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI. The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4.
Time frame: Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose.
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 3 | 3.6 Percentage of participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 2 | 10.7 Percentage of participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 4 | 3.6 Percentage of participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 1 | 17.9 Percentage of participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 2 | 9.3 Percentage of participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 1 | 27.9 Percentage of participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | Follow-up 3 | 2.3 Percentage of participants |
Secondary
RECIST 1.1 Overall Response by Follow-up Assessment Visit
For each follow-up imaging assessment by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI: the number of participants with an overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4.
Time frame: Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose.
Population: ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Complete Response | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Partial Response | 3 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Stable Disease | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Progressive Disease | 6 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Complete Response | 3 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Partial Response | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Stable Disease | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Progressive Disease | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Complete Response | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Partial Response | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Stable Disease | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Progressive Disease | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Complete Response | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Partial Response | 1 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Stable Disease | 0 Participants |
| 177Lu-PSMA-617 (6.0 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Progressive Disease | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Progressive Disease | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Complete Response | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Complete Response | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Partial Response | 4 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Complete Response | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Stable Disease | 7 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Partial Response | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 1 | Progressive Disease | 9 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Stable Disease | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Complete Response | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Stable Disease | 1 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Partial Response | 3 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 4 | Partial Response | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Stable Disease | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 3 | Progressive Disease | 0 Participants |
| 177Lu-PSMA-617 (7.4 GBq) | RECIST 1.1 Overall Response by Follow-up Assessment Visit | Follow-up 2 | Progressive Disease | 1 Participants |