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Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
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.
Study details:
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 consolidation therapy with stereotactic ablative body radiotherapy (SABR) may improve progression free survival (PFS) and overall survival (OS).
This approach has been tested in the setting of lung cancer, in which consolidation SABR has resulted in OS benefit (HR of 0. 40) in phase II studies. The novel approach of local consolidation therapy has not been tested as yet in mCRPC.
The secondary objective of this study proposal is to better understand the pattern of disease distribution at first diagnosis of CRPC. Previous studies have used conventional bone scan and CT imaging, and with these investigations the proportion of patients that are 'M0' is \~35%1. However, in the new era of PSMA PET, which is far more sensitive than conventional imaging, there exists a new group of men who are M0 on conventional imaging but are M1 on PSMA PET staging.
Thus, in the DECREASE study population, we expect the vast majority of patients with conventionally imaged 'M0 CRPC' will have disease detectable on PSMA PET scanning. In this context, the central hypothesis of this trial is that the addition of consolidation radiotherapy to darolutamide to PSMA detected sites of disease will improve the clinical outcome of patients compared to those patients receiving darolutamide alone.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2021-06-02
Primary completion: 2026-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT04319783
Intervention or treatment
DRUG: Darolutamide
RADIATION: Radiotherapy
Conditions
- • Advanced Prostate Carcinoma
- • Cancer of Prostate
- • PSA
- • Castrate Resistant Prostate Cancer
Find a site
Closest Location:
Calvary Mater Newcastle
Research sites nearby
Select from list below to view details:
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Darolutamide
| DRUG: Darolutamide
|
EXPERIMENTAL: Local consolidation Radiotherapy + Darolutamide
| DRUG: Darolutamide
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Undetectable PSA at 12 months | Undetectable PSA at 12 months | 12 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
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