An Experimental Imaging Scan to Treat Your Prostate Cancer Recurrence with Radiation Therapy
Technical Title: Phase III randomized trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]
UCLA Cancer Center Identifier: 18-000484
ClinicalTrials.gov Identifier: NCT03582774
Disease Type: Recurrent prostate cancer after surgery
A rising PSA after radical prostatectomy (surgery that removes the prostate for prostate cancer) means that the prostate cancer has come back somewhere. Salvage radiotherapy, the standard of care treatment for recurrent prostate cancer after radical prostatectomy, can successfully eliminate the recurrent prostate cancer and can offer long-term biochemical control. Salvage radiotherapy targets the prostate bed and often the pelvic lymph nodes because the prostate cancer often recurs in these areas. The radiotherapy is targeted to these areas usually without radiographically visible disease on standard-of-care imaging.
68Ga-PSMA-11 PET/CT is an experimental scan that can sometimes detect recurrent regional and distant metastatic prostate cancer at lower PSA levels than standard of care imaging. However, it is unclear if incorporation of 68Ga-PSMA-11 PET/CT imaging into the planning of salvage radiotherapy could improve its likelihood of success. The purpose of this research study is to determine whether 68Ga-PSMA-11 PET/CT can increase the success rate of salvage prostate radiotherapy.
Research Procedures (not a complete list):
Patients randomized to the control arm (without 68Ga-PSMA-11 PET/CT) will receive standard-of-care salvage radiation therapy.
Patients randomized to the investigational arm will undergo a free 68Ga-PSMA-11 PET/CT scan at UCLA Nuclear Medicine before salvage radiation therapy planning (free for patients, sponsored by UCLA Nuclear Medicine).
The radiation oncologist may change the radiation plan depending on the findings of the 68Ga-PSMA-11 PET/CT scan.
The salvage radiotherapy will be done per routine care, and typically takes place over about two months (daily, Monday through Friday). We will follow you (by phone call, email or in person) up to 5 years after randomization. You will also receive standard of care follow-up by your treating radiation oncologist.
Eligibility Criteria (not a complete list):
1) Histopathology proven prostate cancer
2) Planned salvage radiotherapy for recurrence after radical prostatectomy
3) PSA ≥ 0.1ng/ml at time of enrollment
4) Willingness and a plan 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
1) Extra-pelvic metastasis on any imaging or biopsy
2) Prior PSMA PET/CT
3) Prior pelvic 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.
Jeremie Calais, MD, Principal Investigator: