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Clinical Trial NCT04319783 (DECREASE) for Advanced Prostate Carcinoma, Cancer of Prostate, PSA, Castrate Resistant Prostate Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) Phase 2 65
Clinical Trial NCT04319783 (DECREASE) is designed to study Treatment for Advanced Prostate Carcinoma, Cancer of Prostate, PSA, Castrate Resistant Prostate Cancer. It is a Phase 2 interventional study that is active, not recruiting, having started on June 2, 2021, with plans to enroll 65 participants. Led by Trans Tasman Radiation Oncology Group, it is expected to complete by June 1, 2026. The latest data from ClinicalTrials.gov was last updated on August 21, 2025.
Brief Summary
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.
Detailed Description
This study explores the use of local consolidation therapy in the setting of Darolutamide in the initial diagnosis of metastatic castrate resistant prostate cancer (mCRPC). In the chemotherapy naïve mCRPC setting, the pattern of disease is of limited volume metastases (1-5) in 34%-40% of cases. As progression at known sites of macroscopic disease is the predominant cause of failure on systemic therapies, local consol...Show More
Official Title
Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
Conditions
Advanced Prostate CarcinomaCancer of ProstatePSACastrate Resistant Prostate CancerOther Study IDs
- DECREASE
- TROG 19.06
- U1111-1242-9233 (Other Identifier) (UTN- World Health Organisation)
NCT ID Number
Start Date (Actual)
2021-06-02
Last Update Posted
2025-08-21
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
65
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Darolutamide
Consolidation Radiotherapy
PSA
PSMA PET
Prostate Cancer
Advanced Prostate Cancer
Consolidation Radiotherapy
PSA
PSMA PET
Prostate Cancer
Advanced Prostate Cancer
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDarolutamide Darolutimide 600mg BD | Darolutamide Darolutamide alone |
ExperimentalLocal consolidation Radiotherapy + Darolutamide 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 | Darolutamide Darolutamide alone Radiotherapy Darolutamide + Consolidation Radiotherapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Undetectable PSA at 12 months | Undetectable PSA at 12 months | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Radiological progression free survival | Radiological progression free survival | 36 months |
Distribution of disease on baseline PSMA-PET/CT imaging | Distribution of bone, nodal, visceral and recurrent primary disease on PSMA-PET/CT | 36 months |
Biochemical progression free survival | Biochemical progression free survival | 36 months |
Treatment related adverse event | Treatment related adverse events (CTCAE v 5.0) | 36 months |
Overall survival | Overall survival | 36 months |
Patterns of disease on PSMA PET/CT after 12 weeks of commencing Darolutamide, and at time of disease progression | PSMA avid disease at irradiated site / unirradiated site / bone / local / nodal / visceral | 3 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
≥ 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
- 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
Trans Tasman Radiation Oncology Group- Peter MacCallum Cancer Centre, Australia
No contact data.
16 Study Locations in 2 Countries
New South Wales
St Vincent's Hospital, Darlinghurst, New South Wales, 2101, Australia
GenesisCare Hurstville, Hurstville, New South Wales, 2220, Australia
GenesisCare North Shore, Saint Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle, Waratah, New South Wales, 2298, Australia
Queensland
Royal Brisbane and Women's Hospital, Herston, Queensland, 4006, Australia
Princess Alexandra Hospital (ROPART), Raymond Terrace, Queensland, 4101, Australia
Princess Alexandra Hospital (ROPAIR), Woolloongabba, Queensland, 4102, Australia
South Australia
Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia
Tasmania
Royal Hobart Hospital, Hobart, Tasmania, 7000, Australia
Victoria
Peter MacCallum Cancer Centre, Bendigo, Bendigo, Victoria, 3550, Australia
Peter MacCallum Cancer Centre, Box Hill, Box Hill, Victoria, 3128, Australia
Peter MacCallum Cancer Centre, Parkville, Melbourne, Victoria, 3002, Australia
Icon Cancer Centre Epworth, Richmond, Victoria, 3121, Australia
Western Health, St Albans, Victoria, 3021, Australia
Western Australia
GenesisCare Fiona Stanley Hospital, Murdoch, Western Australia, 6150, Australia
National Cancer Centre Singapore, Singapore, 168583, Singapore