Clinical trial · Interventional
Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
NCT04319783CI-TRIAL-00093959DECREASEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that \>90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Castrate Resistant Prostate Cancer | — | UNRESOLVED | — |
| PSA | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darolutamide | Drug | Darolutamide | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Darolutamide
- description
- Darolutimide 600mg BD
- interventionNames
- Drug: Darolutamide
- type
- EXPERIMENTAL
- label
- Local consolidation Radiotherapy + Darolutamide
- description
- Darolutimide 600mg BD + local consolidative radiotherapy, with a biological equivalent dose of 30Gy/10fx or greater if delivered with SABR. SABR is the preferred treatment approach, however conventional radiotherapy is acceptable. To up to 5 sites of disease
- interventionNames
- Drug: Darolutamide
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Undetectable PSA at 12 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age and provided written Informed Consent * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * Castration-resistant prostate cancer, defined as at least 2 consecutive PSA rises obtained at least 1 week apart in the setting of castrate testosterone levels * Castrate level of serum testosterone (\<1.7 nmol/l \[50 ng/dl\]) on gonadotrophin - releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy * A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less * Adequate bone marrow reserve and organ function Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions; At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions: * Local recurrence within the prostate gland or prostate bed * Regional lymph node disease (below the aortic bifurcation) * Extra-pelvic lymph node, bone or soft tissue metastatic disease Exclusion Criteria: * Patients with detectable metastases or a history of metastatic disease on conventional imaging * Prior treatment with second-generation androgen receptor (AR) antagonists, CYP17 enzyme inhibitors or oral ketoconazole * Use of oestrogens or 5-α reductase inhibitors or anti-androgens within 28 days before randomisation * Use of systemic corticosteroid with a dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomisation * Radiotherapy within 12 weeks prior to randomisation * Initiation of treatment with an osteoclast-targeted therapy to prevent skeletal-related events within 12 weeks before randomisation * Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV * Uncontrolled hypertension * Prior malignancy * Gastrointestinal disorder or procedure that expects to interfere significantly with the absorption of study treatment * Unable to swallow study medications and comply with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.