Targeted radiotherapy to up to three growing prostate cancer spots in castration‑resistant disease

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 is a single‑arm, multicenter phase II trial enrolling 35 men with castration‑resistant metastatic prostate cancer who have oligoprogression (1–3 lesions) on PSMA PET. Eligible patients remain on standard systemic therapy (ADT ± ARTA or prior chemotherapy) and receive metastasis‑directed radiotherapy (MDRT) to all visible progressing lesions. The co‑primary goals are to prolong radiologic progression‑free survival (rPFS) and postpone the start of the next line systemic treatment (NEST). Progression is defined on PSMA PET and patients must be presented to a multidisciplinary tumor board before registration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adenocarcinoma of the prostate.
* mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l.
* Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new metastases and/or the appearance of a local relapse with a maximum of 3 lesions in total.
* Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
* For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).
* WHO performance status 0-2.
* Age \> = 18 years old.
* Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.
* Before patiënt registration, written informed consent must be given according to ICH/GCO and national/local regulations.

Exclusion Criteria:

* Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l.
* Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
* Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.
* Local recurrence in the prostate after previous radiotherapy
* Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
* Disorder precluding understanding of trial Information or informed consent or signing informed consent.
* Evidence of PSMA-negative disease.

Where it's running

• UMC Groningen
  Groningen, Netherlands Recruiting
• Radboud Umc
  Nijmegen, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Shafak Aluwini
• Email: s.al-uwini@umcg.nl
• Phone: +31625649975

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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.