Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
PSMA SRT
Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
4 other identifiers
interventional
193
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2018
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 12, 2027
May 13, 2025
May 1, 2025
8 years
June 19, 2018
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate of salvage radiation therapy (SRT)
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.
From date of initiation of SRT assessed up to 5 years
Secondary Outcomes (4)
Biochemical progression-free survival rate
From date of randomization assessed up to 5 years
Metastasis free survival
Up to 5 years
Initiation of additional salvage therapy after completion of SRT
Up to 5 years
Change in initial treatment intent
Up to 5 years
Study Arms (2)
Arm I (standard of care)
ACTIVE COMPARATORParticipants receive standard of care SRT.
Arm II (68Ga-PSMA-11 PET/CT)
EXPERIMENTALParticipants 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.
Interventions
Undergo standard of care
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Related Publications (2)
Calais J, Armstrong WR, Kishan AU, Booker KM, Hope TA, Fendler WP, Elashoff D, Nickols NG, Czernin J. Update from PSMA-SRT Trial NCT03582774: A Randomized Phase 3 Imaging Trial of Prostate-specific Membrane Antigen Positron Emission Tomography for Salvage Radiation Therapy for Prostate Cancer Recurrence Powered for Clinical Outcome. Eur Urol Focus. 2021 Mar;7(2):238-240. doi: 10.1016/j.euf.2020.12.009. Epub 2020 Dec 30.
PMID: 33386288DERIVEDCalais J, Czernin J, Fendler WP, Elashoff D, Nickols NG. Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]. BMC Cancer. 2019 Jan 7;19(1):18. doi: 10.1186/s12885-018-5200-1.
PMID: 30616601DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2018
First Posted
July 11, 2018
Study Start
July 12, 2018
Primary Completion (Estimated)
July 12, 2026
Study Completion (Estimated)
July 12, 2027
Last Updated
May 13, 2025
Record last verified: 2025-05