PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years. The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT. The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hy

Trial Details

NCT ID
NCT04642027
Phase
PHASE3
Sponsor
University Medical Center Groningen
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Conventional sEBRT
  • Hypofractionated sEBRT
Locations (sample)
  • Arnhem, Gelderland, Netherlands|51.98,5.91111
  • Nijmegen, Gelderland, Netherlands|51.8425,5.85278
  • Maastricht, Limburg, Netherlands|50.84833,5.68889
  • Eindhoven, North Brabant, Netherlands|51.44083,5.47778
  • Tilburg, North Brabant, Netherlands|51.55551,5.0913

Key Eligibility Criteria

  • Patients with prostate adenocarcinoma treated with radical prostatectomy;
  • Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
  • No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
  • PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must b…

For full eligibility, visit ClinicalTrials.gov.

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