Comparing two treatments for 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
PHASE3 · Karolinska University Hospital · NCT04794777
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
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Karolinska University Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 5 sites (Gothenburg, Göteborg and 4 other locations) |
| Trial ID | NCT04794777 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gothenburg, Göteborg and 4 other locations
- Sahlgrenska University Hospital — Gothenburg, Göteborg, Sweden (RECRUITING)
- Södersjukhuset — Stockholm, Stockholm County, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Stockholm County, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, PSMA PET/CT