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Trial registered on ANZCTR


Registration number
ACTRN12612000772842
Ethics application status
Approved
Date submitted
13/07/2012
Date registered
20/07/2012
Date last updated
28/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II pre-operative study of ‘super-castration’ with combination Degarelix, Abiraterone, Bicalutamide and Prednisone in high-risk localized prostate cancer.
Scientific title
Phase II neo-adjuvant study of ‘super-castration’ with combination Degarelix, Abiraterone, Bicalutamide and Prednisone in high-risk localized prostate cancer to assess effects on complete pathological response rates.
Secondary ID [1] 280827 0
Nil
Universal Trial Number (UTN)
U1111-1132-5860
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 286899 0
Condition category
Condition code
Cancer 287220 287220 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open label phase II trial in the neo-adjuvant setting. After signing informed consent, patients will be treated with ‘supercastration’ triple therapy (degarelix 240/80 mg subcutaneously once a month, bicalutamide 50 mg orally once a day, abiraterone 1000 mg orally once a day, prednisone 5 mg orally once a day) for a period of 6 months prior to radical prostatectomy.
Intervention code [1] 285253 0
Treatment: Drugs
Comparator / control treatment
Reported response rate of patients enrolled in neo-adjuvant androgen deprivation trials using older combinations (Gleave et al. 'Randomized comparative study of 3 versus 8-month neoadjuvant hormonal therapy before radical prostatectomy: biochemical and pathological effects' which assessed complete response rates in men treated with 3 or 8 months of combination leuprolide 7.5 mg by intramuscular injection once a month and flutamide 250 mg three times a day orally prior to prostatectomy between August 1995 and April 1998).
Control group
Historical

Outcomes
Primary outcome [1] 287499 0
Safety and tolerability of combined androgen deprivation therapy in the neo-adjuvant setting. This will be assessed by patient history and physical examination (height, weight, vital signs), and regular blood tests (full blood count, urea, creatinine and electrolytes, and liver function tests) as well as evaluation of performance status (ECOG)
Timepoint [1] 287499 0
Every 2 weeks for the first 16 weeks, then every 4 weeks until surgery.
Primary outcome [2] 287500 0
pT0 response rate on histopathological assessment of the radical prostatectomy specimen.
Timepoint [2] 287500 0
6 months
Secondary outcome [1] 298291 0
Rate of organ confined disease on histopathological assessment of the radical prostatectomy specimen.
Timepoint [1] 298291 0
6 months
Secondary outcome [2] 298292 0
Rate of specimen confined disease on histopathological assessment of the radical prostatectomy specimen.
Timepoint [2] 298292 0
6 months
Secondary outcome [3] 298293 0
Correlative molecular studies.
Timepoint [3] 298293 0
6 months

Eligibility
Key inclusion criteria
Histologically confirmed prostate cancer, present in at least 2 biopsy cores, associated with one of the following features: PSA >20 ng/ml, predominant cancer Gleason pattern 4 or above (Gleason 4+3=7, 8-10), clinical stage >/= T2c.
ECOG 0-1
Otherwise suitable for radical prostatectomy with curative intent.
Normal organ and marrow function.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic disease.
Previous systemic therapy for prostate cancer.
Previous local therapy for prostate cancer (radiotherapy, HIFU, cryotherapy)
History of liver disease or baseline bilirubin >/= 1.5 X ULN or Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >/=2.5 X ULN
Uncontrolled hypertension
Clinically significant cardiac disease
History of pituitary or adrenal dysfunction
Hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
18/10/2012
Date of last participant enrolment
Anticipated
Actual
5/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285619 0
Government body
Name [1] 285619 0
National Health and Medical Research Council
Country [1] 285619 0
Australia
Primary sponsor type
Individual
Name
Dr. Niall Corcoran
Address
Australian Prostate Cancer Research Centre@Epworth
Level 2, 185 Hoddle St,
Richmond, VIC 3121 &
Department of Urology, Royal Melbourne Hospital,
Grattan St., Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 284452 0
Hospital
Name [1] 284452 0
Epworth Hospital
Address [1] 284452 0
89 Bridge Road
Richmond Vic 3121
Country [1] 284452 0
Australia
Other collaborator category [1] 276925 0
Individual
Name [1] 276925 0
Dr. Phil Parente
Address [1] 276925 0
Epworth Eastern Hospital
1 Arnold St,
Box Hill, VIC 3128
Country [1] 276925 0
Australia
Other collaborator category [2] 276926 0
Individual
Name [2] 276926 0
Professor Tony Costello
Address [2] 276926 0
Suite 8.6, The Epworth Centre
32 Erin Street, Richmond, VIC 3121
Country [2] 276926 0
Australia
Other collaborator category [3] 276927 0
Individual
Name [3] 276927 0
Mr. Paul Ruljancich
Address [3] 276927 0
Suite 6, 30 Arnold ST
Box Hill, VIC, 3128
Country [3] 276927 0
Australia
Other collaborator category [4] 276928 0
Individual
Name [4] 276928 0
Mr. Jeremy Grummet
Address [4] 276928 0
Ground Floor 322 Glenferrie Road,
Malvern VIC 3144 &
The Alfred Hospital,
Commercial Road,
Melbourne. Vic. 3004
Country [4] 276928 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287625 0
Epworth Human Research Ethics Committee
Ethics committee address [1] 287625 0
Epworth Hospital Richmond,
89 Bridge Road
Richmond Vic 3121
Ethics committee country [1] 287625 0
Australia
Date submitted for ethics approval [1] 287625 0
Approval date [1] 287625 0
23/05/2012
Ethics approval number [1] 287625 0
55512

Summary
Brief summary
This study aims to evaluate the safety and efficacy of combination Degarelix, Abiraterone, Bicalutamide and Prednisolone in high-risk localised prostate cancer patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Trial details All participants in this trial will be treated with 'super castration' triple therapy. This involves taking the medications Degarelix, Bicalutamide, Abiraterone and Prednisone for a period of 6 months prior to radical prostatectomy.

Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34426 0
Dr Niall Corcoran
Address 34426 0
5th Floor Clinical Sciences Building
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 34426 0
Australia
Phone 34426 0
+61393427000
Fax 34426 0
Email 34426 0
[email protected]
Contact person for public queries
Name 17673 0
Ms Pat Bugeja
Address 17673 0
Australian Prostate Cancer Research Centre Epworth
Level 2, 185 Hoddle St,
Richmond, VIC 3121, Australia
Country 17673 0
Australia
Phone 17673 0
+61 3 9936 8032
Fax 17673 0
+61 3 9429 4683
Email 17673 0
[email protected]
Contact person for scientific queries
Name 8601 0
Dr. Niall Corcoran
Address 8601 0
Australian Prostate Cancer Research Centre Epworth
Level 2, 185 Hoddle St,
Richmond, VIC 3121, Australia
Country 8601 0
Australia
Phone 8601 0
+61 3 9936 8032
Fax 8601 0
+61 3 9429 4683
Email 8601 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAndrogen deprivation therapy promotes an obesity-like microenvironment in periprostatic fat.2019https://dx.doi.org/10.1530/EC-19-0097
EmbaseLoss of SNAI2 in prostate cancer correlates with clinical response to androgen deprivation therapy.2021https://dx.doi.org/10.1200/PO.20.00337
N.B. These documents automatically identified may not have been verified by the study sponsor.