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| ID | Type | Description | Link |
|---|---|---|---|
| PROS0098 | Other Identifier | OnCore | |
| NCI-2020-02779 | Registry Identifier | CTRP | |
| 1R01CA230438 | U.S. NIH Grant/Contract | View source |
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Lack of accrual due to pandemic and logistics
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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)
Primary Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI | Experimental | Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi) |
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| 68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI | Experimental | Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68-Ga RM2. | Drug | PET radiopharmaceutical |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment |
| 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. | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment |
| 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei H Iagaru, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94304 | United States |
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4 participants signed consent and three participants were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PSMA 11 PET/MRI. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-HDR Scan Sequence |
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| HDR Treatment at 2 Months |
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| Post-HDR Scan Sequence at 10 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with pre HDR treatment scan data | Posted | Count of Participants | Participants | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment |
|
up to 13 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68Ga-RM2 PET MRI | Subjects receive 68Ga RM2 PET/MRI. | 0 |
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Early termination led to a small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrei Iagaru, MD | Stanford University | (650) 725-4711 | aiagaru@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2019 | Sep 21, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 18, 2022 | Sep 21, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582579 | BAY 86-7548 |
| C000718244 | gallium 68 PSMA-11 |
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| 68-Ga PSMA11 | Drug | PET radiopharmaceutical |
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| PET/MRI | Device | PET/MR scanner by GE healthcare |
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| NOT COMPLETED |
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| Received Second Scan in Sequence |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects will undergo 68Ga PSMA 11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| 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. | Participants who received post HDR scan | Posted | Count of Participants | Participants | Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment |
|
|
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| 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. | No participant had month 24 data (all discontinued prior) | Posted | 24 months |
|
|
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 68Ga-PSMA-11 PET MRI | Subjects receive 68Ga PSMA11 PET/MRI. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |