Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
NCT ID: NCT03582774
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
193 participants
INTERVENTIONAL
2018-07-12
2027-07-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm I (standard of care)
Participants receive standard of care SRT.
Best Practice
Undergo standard of care
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.
Computed Tomography
Undergo PET/CT
Gallium Ga 68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo PET/CT
Interventions
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Best Practice
Undergo standard of care
Computed Tomography
Undergo PET/CT
Gallium Ga 68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeremie Calais
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Countries
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References
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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.
Calais 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.
Other Identifiers
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NCI-2018-01518
Identifier Type: REGISTRY
Identifier Source: secondary_id
NUC MED 18-000484
Identifier Type: -
Identifier Source: secondary_id
18-000484
Identifier Type: OTHER
Identifier Source: secondary_id
18-000484
Identifier Type: -
Identifier Source: org_study_id
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