Actively Recruiting
Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
Led by Stefan Carlsson · Updated on 2025-03-20
450
Participants Needed
5
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sahlgrenska University Hospital
Gothenburg, Göteborg, Sweden, 413 45
Actively Recruiting
2
Södersjukhuset
Stockholm, Stockholm County, Sweden, 118 83
Not Yet Recruiting
3
Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
4
Norrland's University Hospital
Umeå, Sweden, 901 85
Not Yet Recruiting
5
Örebro University Hospital
Örebro, Örebro County, Sweden, 701 85
Not Yet Recruiting
Research Team
S
Stefan Carlsson
CONTACT
Y
Yvonne Larsen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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