Actively Recruiting
The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
Led by University Medical Center Groningen · Updated on 2025-06-26
35
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adenocarcinoma of the prostate
- Metastatic castration-resistant prostate cancer with testosterone level below 50 ng/dl or 1.7 nmol/l
- Oligoprogressive disease diagnosed on PSMA scan with up to 3 lesions including metastatic and/or local relapse
- Currently treated with androgen deprivation therapy alone or combined with ARTA or chemotherapy
- Completed or stopped chemotherapy before starting MDRT
- At least 3 months response to ARTA if previously treated
- WHO performance status between 0 and 2
- Age 18 years or older
- Presentation at multidisciplinary tumor board at local hospital
- Provided written informed consent according to regulations
You will not qualify if you...
- Serum testosterone level above 50 ng/ml or 1.7 nmol/l
- More than 3 progressive or new metastatic lesions and/or local recurrence
- Active malignancy other than prostate cancer except non-melanoma skin cancer or non-invasive urothelial carcinoma
- Local recurrence in prostate after previous radiotherapy
- Previous treatments or comorbidities preventing new MDRT treatment
- Cognitive or other disorders preventing understanding or signing informed consent
- Evidence of PSMA-negative disease
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UMC Groningen
Groningen, Netherlands
Actively Recruiting
2
Radboud Umc
Nijmegen, Netherlands
Not Yet Recruiting
Research Team
S
Shafak Aluwini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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