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PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

RecruitingPhase 3Ages 18 Years - 80 YearsMaleUniversity Medical Center Groningen
NCT04642027 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 hypofractionated schedule of 20 x 3 = 60 Gy. The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA \< 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will

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📋 Eligibility rules (as published)
Inclusion 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 be measured at least 6 weeks after radical prostatectomy; * PSA at inclusion \< 1.0 ng/mL; * WHO performance status 0-2 at inclusion; * Age at inclusion between 18 and 80 years; * Written (signed and dated) informed consent prior to registration. Exclusion Criteria: * Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy; * Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers; * Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration; * Double-sided metallic hip prosthesis; * Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
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What it tests

  • Conventional sEBRT
  • Hypofractionated sEBRT
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Where

13 sites
Radiotherapiegroep
Arnhem, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Maastro Clinic
Maastricht, Netherlands
Catharina-Hospital
Eindhoven, Netherlands
Verbeeten Institute
Tilburg, Netherlands
Amsterdam UMC (Location VUmc)
Amsterdam, Netherlands
Radiotherapiegroep
Deventer, Netherlands
Radiotherapy Institute Friesland
Leeuwarden, Netherlands

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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