Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy (PSMA SRT)
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ClinicalTrials.gov Identifier: NCT03582774 |
Recruitment Status :
Active, not recruiting
First Posted : July 11, 2018
Last Update Posted : February 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Recurrent Prostate Carcinoma | Other: Best Practice Procedure: Computed Tomography Radiation: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography | Phase 3 |
PRIMARY OBJECTIVE:
I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.
SECONDARY OBJECTIVES:
I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization).
III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. Change in initial treatment intent.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive standard of care SRT.
ARM II: Participants receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
After conclusion of PET/CT, participants are followed up periodically for up to 5 years.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 193 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT] |
Actual Study Start Date : | July 12, 2018 |
Estimated Primary Completion Date : | July 12, 2023 |
Estimated Study Completion Date : | July 12, 2024 |

Arm | Intervention/treatment |
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Active Comparator: Arm I (standard of care)
Participants receive standard of care SRT.
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Other: Best Practice
Undergo standard of care
Other Names:
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Experimental: Arm II (68Ga-PSMA-11 PET/CT)
Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
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Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Radiation: Gallium Ga 68-labeled PSMA-11 Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo PET/CT
Other Names:
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- Success rate of salvage radiation therapy (SRT) [ Time Frame: From date of initiation of SRT assessed up to 5 years ]Will be measured as biochemical progression-free survival after initiation of SRT. Will use a log rank test to compare progression free survival time between the two randomized treatment arms.
- Biochemical progression-free survival rate [ Time Frame: From date of randomization assessed up to 5 years ]Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., androgen deprivation therapy [ADT], pelvic lymph node radiation therapy [LN RT], prostate specific antigen [PSA] doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
- Metastasis free survival [ Time Frame: Up to 5 years ]Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
- Initiation of additional salvage therapy after completion of SRT [ Time Frame: Up to 5 years ]Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
- Change in initial treatment intent [ Time Frame: Up to 5 years ]Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathology proven prostate cancer.
- Planned SRT for recurrence after primary prostatectomy.
- Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
- Willingness to undergo radiotherapy.
- Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.
Exclusion Criteria:
- Extra-pelvic metastasis on any imaging or biopsy.
- Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
- Contraindications to radiotherapy (including active inflammatory bowel disease).
- Concurrent systemic therapy for prostate cancer with investigational agents.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582774
United States, California | |
UCLA / Jonsson Comprehensive Cancer Center | |
Los Angeles, California, United States, 90095 | |
UCSF Medical Center-Mount Zion | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Jeremie Calais | UCLA / Jonsson Comprehensive Cancer Center |
Responsible Party: | Jonsson Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT03582774 |
Other Study ID Numbers: |
18-000484 NCI-2018-01518 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) NUC MED 18-000484 18-000484 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center ) P30CA016042 ( U.S. NIH Grant/Contract ) |
First Posted: | July 11, 2018 Key Record Dates |
Last Update Posted: | February 4, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
PSMA PET/CT salvage radiation therapy randomized trial |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Edetic Acid |
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