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Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

NCT04641078 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-02-28

No results posted yet for this study

Summary

The current trial will test the combination of darolutamide with SBRT, in oligometastatic recurrent hormone sensitive prostate cancer. We hypothesize that the addition of short-term darolutamide improves metastasis-free survival when added to SBRT without a detrimental impact on the QoL. Considering the large reluctance of both patients and physicians to be randomized to observation, we propose to use the historical data from previous reported randomized trials (STOMP and ORIOLE) as a comparator to explore as a secondary endpoint.

Conditions

Interventions

DRUG

Darolutamide

600 mg BID

RADIATION

metastasis-directed treatment

stereotactic body radiotherapy

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Piet Ost, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2026-02-12
Completion
2026-02-12

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641078 on ClinicalTrials.gov