Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT07038304

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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