Comparing “Salvage” Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
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
About This Trial
- This clinical trial is testing whether using an advanced body scan to create a personalized treatment plan works better than standard radiation for prostate cancer that has returned.
- It is designed for men who had surgery to remove their prostate and are now seeing their PSA blood test levels begin to rise again.
- To qualify, you must not have received radiation or hormone therapy since your initial surgery.
- Before considering this trial, you should know that you will be randomly assigned to receive either standard radiation or a targeted treatment guided by your scan results.
- Researchers will follow your progress over time through regular blood tests and questionnaires to see how the treatment affects your health and daily well-being.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing whether using an advanced body scan to create a personalized treatment plan works better than standard radiation for prostate cancer that has returned.
Study Details
- Start Date: October 30, 2018
- Lead Sponsor: Stefan Carlsson
Full Eligibility Criteria
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
Treatments
- Combination Product: Individualised therapy
- Radiation: Standard salvage therapy