Clinical trial · Interventional
Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68-labeled PSMA-11 | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard of care)
- description
- Participants receive standard of care SRT.
- interventionNames
- Other: Best Practice
- type
- EXPERIMENTAL
- label
- Arm II (68Ga-PSMA-11 PET/CT)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography
- Radiation: Gallium Ga 68-labeled PSMA-11
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDNikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102. PMID 41698328
- DERIVEDCalais 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 33386288
- DERIVEDCalais 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 30616601