Radiotherapy for recurrent prostate cancer using PSMA-PET guidance

Is this trial a fit for you?

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 investigates the effectiveness of hypofractionated salvage external beam radiation therapy (sEBRT) in men who have experienced biochemical recurrence of prostate cancer after radical prostatectomy. The study aims to improve oncologic outcomes by increasing the biological effective radiation dose through a specific treatment schedule. Participants will be randomly assigned to receive either conventional sEBRT or the hypofractionated approach, with eligibility criteria focusing on specific PSA levels and absence of metastases. The trial is designed as a multicenter phase III study to gather comprehensive data on treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radiotherapiegroep
  Arnhem, Gelderland, Netherlands Recruiting
• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Recruiting
• Maastro Clinic
  Maastricht, Limburg, Netherlands Recruiting
• Catharina-Hospital
  Eindhoven, North Brabant, Netherlands Recruiting
• Verbeeten Institute
  Tilburg, North Brabant, Netherlands Recruiting
• Radiotherapiegroep
  Deventer, Overijssel, Netherlands Recruiting

Study contacts

• Principal investigator: S. Aluwini, Dr. — University Medical Center Groningen
• Study coordinator: F. Staal, MD
• Email: f.h.e.staal@umcg.nl
• Phone: 0031655257985

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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.