Comparing standard radiotherapy with PSMA scan-guided treatment for prostate cancer that returned
Tests scan-guided treatment against standard radiotherapy in men whose prostate cancer returned after surgery.
Plain-language title generated from the registry record
Registry title: Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
Key facts
- Where
- Gothenburg, Orebro, Solna, Stockholm, and Umeå, SwedenSee the 5 sites
- Phase
- Phase 3
Where in Sweden
- Sahlgrenska University Hospital-Vastra GotalandsregionenGothenburg, SwedenTaking people
- Region Oerebro LaenOrebro, SwedenTaking people
- Karolinska University HospitalSolna, SwedenTaking people
- Soedersjukhuset ABStockholm, SwedenTaking people
- Norrlands University HospitalUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stefan Carlsson
- Trial code
- NCT04794777EU 2023-504917-54-00
- Record updated
- 20 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.