Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer

Recruiting now · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04794777

Run by

Stefan Carlsson

People needed

450

Starts

2018-10-30

Expected to finish

2027-10-30

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Sahlgrenska University Hospital — Gothenburg, Göteborg, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Stockholm County, Sweden (enrolling)
• Södersjukhuset — Stockholm, Stockholm County, Sweden
• Norrland's University Hospital — Umeå, Sweden
• Örebro University Hospital — Örebro, Örebro County, Sweden

Full record on ClinicalTrials.gov

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