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NCT06276465: PEACE8
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
Phase 3 trial testing Darolutamide 300 mg in Prostatic Cancer, Castration-Resistant in 336 participants. Currently enrolling.
15 October 2029
Quick facts
| Lead sponsor | UNICANCER |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 336 |
| Start date | 7 October 2024 |
| Primary completion | 15 October 2029 |
| Estimated completion | 7 October 2032 |
| Sites | 4 locations across France |
Drugs / interventions tested
- Darolutamide 300 mg — full drug profile →
- Stereotactic body radiation therapy — full drug profile →
- Androgen deprivation therapy — full drug profile →
Conditions studied
- Prostatic Cancer, Castration-Resistant — all drugs for Prostatic Cancer, Castration-Resistant →
Sponsor
UNICANCER — full company profile →
Who can join
18 and older, male only, with Prostatic Cancer, Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Role of SBRT in Oligometastatic Prostate Cancer: Where We Are and Where We Are Heading.
Teja M, Berenguer Frances MA, López Campos F, Feltes Benítez N, et al · · 2026 · PMID 42073360 · DOI 10.3390/life16040550
Verify or expand the search:
- PubMed search for NCT06276465
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Darolutamide 300 mg
Trials testing the same drug.
- NCT05249712 — Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer · Phase 2 · unknown
Other recruiting trials for Prostatic Cancer, Castration-Resistant
Currently open trials in the same condition.
- NCT07047118 — A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration R · Phase 2 · active not recruiting
Other UNICANCER trials
Trials by the same sponsor.
- NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
- NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
- NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
- NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
- NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06276465 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNICANCER
- Last refreshed: 20 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06276465.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing