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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04319783




Registration number
NCT04319783
Ethics application status
Date submitted
9/03/2020
Date registered
24/03/2020

Titles & IDs
Public title
Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
Scientific title
Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
Secondary ID [1] 0 0
U1111-1242-9233
Secondary ID [2] 0 0
TROG 19.06
Universal Trial Number (UTN)
Trial acronym
DECREASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Prostate Carcinoma 0 0
Cancer of Prostate 0 0
PSA 0 0
Castrate Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide
Treatment: Other - Radiotherapy

Experimental: Darolutamide - Darolutimide 600mg BD

Experimental: Local 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


Treatment: Drugs: Darolutamide
Darolutamide alone

Treatment: Other: Radiotherapy
Darolutamide + Consolidation Radiotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Undetectable PSA at 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Radiological progression free survival
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Distribution of disease on baseline PSMA-PET/CT imaging
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Biochemical progression free survival
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Treatment related adverse event
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Patterns of disease on PSMA PET/CT after 12 weeks of commencing Darolutamide, and at time of disease progression
Timepoint [6] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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-a 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
GenesisCare Hurstville - Hurstville
Recruitment hospital [3] 0 0
GenesisCare North Shore - Saint Leonards
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Princess Alexandra Hospital (ROPART) - Raymond Terrace
Recruitment hospital [8] 0 0
Princess Alexandra Hospital (ROPAIR) - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre, Bendigo - Bendigo
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre, Box Hill - Box Hill
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Centre, Parkville - Melbourne
Recruitment hospital [14] 0 0
Icon Cancer Centre Epworth - Richmond
Recruitment hospital [15] 0 0
Western Health - St Albans
Recruitment hospital [16] 0 0
GenesisCare Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2101 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4006 - Herston
Recruitment postcode(s) [7] 0 0
4101 - Raymond Terrace
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3550 - Bendigo
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3002 - Melbourne
Recruitment postcode(s) [14] 0 0
3121 - Richmond
Recruitment postcode(s) [15] 0 0
3021 - St Albans
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Peter MacCallum Cancer Centre, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shankar Siva
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Montgomery
Address 0 0
Country 0 0
Phone 0 0
+61 2 4014 3910
Fax 0 0
Email 0 0
decrease@trog.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04319783