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

RecruitingPhase 2Ages 18 Years - anyMaleUniversity Medical Center Groningen
NCT07038304 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Oligopro

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📋 Eligibility rules (as published)
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.
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What it tests

  • Metastasis directed radiotherapy
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Where

2 sites
UMC Groningen
Groningen, Netherlands
Radboud Umc
Nijmegen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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