Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
UMC Groningen
RECRUITING
Groningen
Radboud Umc
NOT_YET_RECRUITING
Nijmegen
Contact Information
Primary
Shafak Aluwini
s.al-uwini@umcg.nl
+31625649975
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2029-01-03
Participants
Target number of participants: 35
Treatments
Experimental: MDRT to oligoprogression
Patients included in the study with a post prostatectomy local recurrence on the PSMA PET with up to 3 oligometastases will be treated preferably with SBRT to all oligometastatic lesions and to the local recurrence in prostate bed
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov

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