RecruitingPhase 2NCT07038304

The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)

Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer


Sponsor

University Medical Center Groningen

Enrollment

35 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether targeted radiation therapy (metastasis-directed radiotherapy) to specific tumor sites can delay cancer progression in men with castration-resistant prostate cancer (CRPC) whose disease is progressing in only a few spots while they are already on systemic treatment. **You may be eligible if...** - You have prostate cancer that is no longer responding to hormone therapy (castration-resistant) - Your testosterone level is very low (below 50 ng/dl) - You have a limited number of progressing spots identified on a PSMA scan - You are currently on a systemic cancer treatment **You may NOT be eligible if...** - Your cancer has spread to many sites throughout the body - Your overall health is too poor to tolerate radiation - You have already received radiation to all progressing sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONMetastasis directed radiotherapy

According to guidelines, in the case of oligoprogression next line systemic treatment is recommended. This study investigates the potential delay of NEST and rPFS by MDRT.


Locations(2)

UMC Groningen

Groningen, Netherlands

Radboud Umc

Nijmegen, Netherlands

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NCT07038304


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