Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 193
• Participant gender: Male

Summary

To evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

1. Histopathology proven prostate cancer

2. Planned SRT for recurrence after primary prostatectomy

3. PSA ≥ 0.1ng/ml at time of enrollment

4. Willingness to undergo radiotherapy.

5. 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:

1. Extra-pelvic metastasis on any imaging or biopsy

2. Prior PSMA PET/CT

3. Prior pelvic external beam radiation therapy (RT)

4. Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT

5. Contraindications to radiotherapy (including active inflammatory bowel disease)

6. Concurrent systemic therapy for prostate cancer with investigational agents. -