Targeted radiotherapy to up to three growing prostate cancer spots in castration‑resistant disease
Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer
This trial will try adding targeted radiotherapy to up to three progressing spots to see if it can delay the next systemic treatment and extend disease control in men with oligoprogressive castration‑resistant prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Groningen and 1 other locations) |
| Trial ID | NCT07038304 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men with adenocarcinoma of the prostate in the castration‑resistant setting, on ADT (with or without ARTA or prior chemotherapy), WHO performance status 0–2, and PSMA‑PET‑confirmed oligoprogression of no more than three lesions.
Not a fit: Patients with more than three progressing lesions, widespread/rapid systemic progression, or non‑PSMA‑avid disease are unlikely to benefit from this targeted radiotherapy approach.
Why it matters
Potential benefit: If successful, the approach could delay the need for further systemic therapy and prolong the time without radiographic progression.
How similar studies have performed: Previous smaller series and trials of metastasis‑directed therapy in oligometastatic prostate cancer have shown delays to further systemic therapy, but data specifically in oligoprogressive mCRPC remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Groningen and 1 other locations
- 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
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.