Prostate Cancer
Conditions
Brief summary
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)
Detailed description
Primary Objective: 1. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. 2. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.
Interventions
DRUG68-Ga RM2.
PET radiopharmaceutical
DRUG68-Ga PSMA11
PET radiopharmaceutical
DEVICEPET/MRI
PET/MR scanner by GE healthcare
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Andrei Iagaru
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be at least 18 years of age; * Patients must be able to provide informed consent; * Histologically proven low-grade or intermediate-grade prostate cancer (PC) * Scheduled to undergo targeted local therapy (HDR brachytherapy).
Exclusion criteria
* Inability to lie still for the entire imaging time; * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.); * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance; * Metallic implants (contraindicated for MRI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Assessment of PET Based PC Lesions | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment | Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans. |
| Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment | Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Progression Free Survival (PFS) | 24 months | Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression. |
Countries
United States
Participant flow
Pre-assignment details
4 participants signed consent and three participants were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PSMA11 PET/MRI. | 1 |
| 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI Subjects will undergo 68Ga PSMA 11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained
Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Population: Participants who received post HDR scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-RM2 PET MRI | Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained | 1 Participants |
| 68Ga-PSMA-11 PET MRI | Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained | 1 Participants |
Primary
Number of Participants With Successful Assessment of PET Based PC Lesions
Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans.
Time frame: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Population: Participants with pre HDR treatment scan data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-RM2 PET MRI | Number of Participants With Successful Assessment of PET Based PC Lesions | 2 Participants |
| 68Ga-PSMA-11 PET MRI | Number of Participants With Successful Assessment of PET Based PC Lesions | 2 Participants |
Primary
Progression Free Survival (PFS)
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.
Time frame: 24 months
Population: No participant had month 24 data (all discontinued prior)