PSMA SRT: Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
Study Details
Study Description
Brief Summary
This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVE:
- Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.
SECONDARY OBJECTIVES:
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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).
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (standard of care) Participants receive standard of care SRT. |
Other: Best Practice
Undergo standard of care
Other Names:
|
| 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. |
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:
|
Outcome Measures
Primary Outcome Measures
- Success rate of salvage radiation therapy (SRT) [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.
Secondary Outcome Measures
- Biochemical progression-free survival rate [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 [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 [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 [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathology proven prostate cancer.
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Planned SRT for recurrence after primary prostatectomy.
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Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
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Willingness to undergo radiotherapy.
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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:
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Extra-pelvic metastasis on any imaging or biopsy.
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Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
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Contraindications to radiotherapy (including active inflammatory bowel disease).
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Concurrent systemic therapy for prostate cancer with investigational agents.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 2 | UCSF Medical Center-Mount Zion | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jeremie Calais, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-000484
- NCI-2018-01518
- NUC MED 18-000484
- 18-000484
- P30CA016042