A Randomized Trial Comparing Conventional "salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients with Biochemical Recurrence After Prostate Cancer Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 450
- Locations
- 10
- Primary Endpoint
- Primary PSA progression free survival
Study Overview
Brief Summary
Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.
Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.
In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
- •Multidisciplinary conference (MDK) decision to offer the patient SRT
- •Signed Informed Consent
Exclusion Criteria
- •Patients previously treated for prostate cancer with biochemical recurrence
- •Previous treatment with androgen deprivation therapy (ADT) after surgery
- •Previous pelvic radiotherapy
- •Patients with positive lymph nodes at surgery
Outcomes
Primary Outcomes
Primary PSA progression free survival
Time Frame: Throughout the study, approximately 10 years.
Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement
Secondary Outcomes
- Time to secondary treatment(At 5, 7 and 10 years)
- Prostate cancer specific survival(At 5, 7 and 10 years)
- Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)(Baseline, 6, 12, 36 and 60 months after completed treatment.)
- Time to metastasis(At 5, 7 and 10 years)
Investigators
Stefan Carlsson
Principal Investigator
Karolinska University Hospital