NCT07038304 The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
| NCT ID | NCT07038304 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2028-01-03 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2025-01-03 with a primary completion date of 2028-01-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years. Treatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and/or local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion/selection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07038304 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07038304 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07038304 currently recruiting?
Yes, NCT07038304 is actively recruiting participants. Contact the research team at s.al-uwini@umcg.nl for enrollment information.
Where is the NCT07038304 trial being conducted?
This trial is being conducted at Groningen, Netherlands, Nijmegen, Netherlands.
Who is sponsoring the NCT07038304 clinical trial?
NCT07038304 is sponsored by University Medical Center Groningen. The trial plans to enroll 35 participants.
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