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Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 and up Men only

Comparing two treatments for relapsing prostate cancer

Official title: 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

Run by Karolinska University Hospital · NCT04794777 · Data updated 2026-11-12

This study is testing whether a new imaging-guided treatment or standard salvage radiotherapy works better for men with prostate cancer that has come back after surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment450 (estimated)
SponsorKarolinska University Hospital
Academic / other
Drugs / interventionsradiation
Locations5 sites (Gothenburg, Göteborg and 4 other locations)
StatusRecruiting
StartedOctober 30, 2018
Main results expectedOctober 30, 2027
Study endsOctober 30, 2027
Registry record updatedMarch 20, 2025
Trial IDNCT04794777 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who have undergone radical prostatectomy and are experiencing biochemical recurrence with PSA levels between 0.2 and 2.0 ng/mL.

Probably not a fit

Patients who have previously received androgen deprivation therapy, pelvic radiotherapy, or have positive lymph nodes at surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares the effectiveness of salvage radiotherapy (SRT) with individualized PSMA PET/CT targeted treatment for patients experiencing biochemical recurrence of prostate cancer after surgery. The study aims to determine which approach better targets preexisting distant metastases and lymph node metastases, as standard imaging techniques often fail to detect recurrence at low PSA levels. By utilizing PSMA PET/CT, the trial seeks to improve treatment outcomes for patients who have not responded adequately to conventional therapies.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with relapsing prostate cancer, potentially improving survival rates and quality of life.

How similar studies have gone: While there is limited data on the impact of PSMA PET/CT in this context, other studies have shown promise in using targeted imaging for prostate cancer treatment.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Sahlgrenska University Hospital
    Gothenburg, Göteborg, Sweden     Recruiting
  • Karolinska University Hospital
    Stockholm, Stockholm County, Sweden     Recruiting
  • Södersjukhuset
    Stockholm, Stockholm County, Sweden     Not yet recruiting
  • Norrland's University Hospital
    Umeå, Sweden     Not yet recruiting
  • Örebro University Hospital
    Örebro, Örebro County, Sweden     Not yet recruiting

Study contacts

  • Principal investigator: Stefan Carlsson — Karolinska University Hospital
  • Study coordinator: Stefan Carlsson
  • Email: stefan.carlsson@ki.se
  • Phone: 0704871106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.