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Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

NCT06276465 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2024-12-20

No results posted yet for this study

Summary

In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.

In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.

An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.

The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.

The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide.

Conditions

  • Prostatic Cancer, Castration-Resistant

Interventions

DRUG

Darolutamide 300 mg

2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation

RADIATION

Stereotactic body radiation therapy

Over one week,30 Gy in 3 fractions of 10 Gy

DRUG

Androgen deprivation therapy

Continuous ADT during the study course. The choice of ADT is left to the discretion of the investigator.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Ronan FLIPPOT, MD · Gustave Roussy (Villejuif, France)

  • David PASQUIER, MD · Centre Oscar Lambret, Lille University (Lille, France)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2029-10-15
Completion
2032-10-07

Countries

  • France

Study Locations

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Entities

Companies

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 NCT06276465 on ClinicalTrials.gov