Treatment with Darolutamide +/- radiation therapy for patients with a castration resistant cancer and metastases detected by functional imaging (PEACE8)
Treatment with Darolutamide +/- radiation therapy for patients with a castration resistant cancer and metastases detected by functional imaging (PEACE8)
ClinicalTrials.gov ID: NCT06276465
Sponsor: UNICANCER
Information provided by: UNICANCER (Responsible Party)
Last Update Posted: 2024-09-19
Brief 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.
Detailed Description:
PEACE 8 is a phase III open-label, randomised (patients are randomly assigned to treatment), international, multicentre trial, evaluating the benefit of adding SBRT to darolutamide for treating patients with oligometastatic CRPC.
Eligible patients will be randomised into either an experimental group receiving darolutamide + SBRT or a control group receiving darolutamide. In both arms, all patients will receive continuous castration (ADT) during the trial course.
Patients' participation in the trial will not exceed 60 months after randomisation, including a maximum treatment duration of 60 months and follow-up up to 60 months after randomisation.
After signing the consent form, patients will enter the pre-inclusion period (before the start of treatment), during which the investigator will carried out all the tests required to assess their eligibility, including demographic data collection, tumour evaluation, and clinical and biological assessments.
Patients will receive doralutamide until disease progression or unacceptable toxicity for a maximum of 5 years after the start of treatment.
To receive treatment, the patient will need to go to hospital, where, at each visit, the medical team will conduct medical examinations before administering the treatment to assess the patient's general state of health and tolerance to the treatment.
Official Title:
Combination of Darolutamide and Stereotactic Body Radiation Therapy in Patients With Castration Resistant Prostate Cancer and Oligometastases on Functional Imaging
Intervention / Treatment:
- Drug: Darolutamide 300 mg
- Radiation: Stereotactic body radiation therapy
- Drug: Androgen deprivation therapy
| Category | Value |
|---|---|
| Study Start (Estimated) |
2024-10-15
|
| Primary Completion (Estimated) |
2029-10-15
|
| Study Completion (Estimated) |
2032-07-01
|
| Enrollment (Estimated) | 336 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
UC-GTG-2306
2023-507482-26-00 (Other Identifier) (OTHER: EU-CT) |