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Trial registered on ANZCTR


Registration number
ACTRN12618001061224
Ethics application status
Approved
Date submitted
20/03/2018
Date registered
26/06/2018
Date last updated
23/07/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II pre-operative study of Androgen Deprivation Therapy (Degarelix) and Erdafitinib in high-risk localized prostate cancer.
Scientific title
ADEPT: Phase II neo-adjuvant study of Androgen Deprivation Therapy (Degarelix) and Erdafitinib in high-risk localized prostate cancer.

Secondary ID [1] 294386 0
None
Universal Trial Number (UTN)
Trial acronym
ADEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 307109 0
Condition category
Condition code
Cancer 306228 306228 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 combination Degarelix 240/80 mg subcutaneously plus Erdafitinib 8 mg orally.. A starting dose of 240 mg of Degarelix is administered as two consecutive subcutaneous injections of 120 mg each, a maintenance dose of 80 mg is administered as one subcutaneous injection for each following month. An initial dose of 8 mg of Erdafitinib is taken orally daily with subsequent up-titration based on serum phosphate levels. Combined Erdafitinib plus Degarelix is given for 3 months, followed by Degarelix alone, for a further 1 month prior to radical prostatectomy. Compliance will be monitored by counting the Erdafitinib capsules at each visit, this will be logged on the drug accountability sheet and signed by the Principal Investigator. Participants will have regular blood tests to keep an eye on any possible side effects from these medications.
Intervention code [1] 300683 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305243 0
Safety and tolerability of combination Degarelix and Erdafitinib in the neo-adjuvant setting.

Participants will undergo blood tests (serum assay), eye examinations (via an ophthalmological examination including; visual acuity, tonometry, fundoscopy, Amsler Grid Test, and Optical Coherence), heart examinations (12-lead ECG) and vital signs (pulse and blood pressure using a Sphygmomanometer, as well as height (stadiometer) and weight (digital scales) checked at regular intervals throughout the study to monitor the possible side effects from these treatments.

These are composite primary outcomes.
Timepoint [1] 305243 0
*Bloods tests (Pre-study visit, Week 1, 3, 5, 7, 9, 13 and 17 pre-surgery, then 4-weeks, 24-weeks and 52-weeks post surgery).

*Eye examinations (visual acuity, tonometry, fundoscopy, and Optical Coherence checked at pre-study visit and again If clinically indicated based on presence of new visual symptoms or abnormal Amsler grid test).

*Eye examinations (Amsler grid test checked at pre-study visit, week 1, 5, 9, 13, 15 and 17 pre-surgery, then 4-weeks, 24-weeks and 52-weeks post-surgery).

*Heart examinations (checked at pre-study visit and week 1, 5, 9 and 13 pre-surgery).

*Vital signs (checked at pre-study visit, week 1, 5, 9, 13 and 17 pre-surgery, and 4-weeks, 24-weeks and 52-weeks post-surgery).
Primary outcome [2] 305244 0
pT0 response rate on histopathological assessment of the radical prostatectomy specimen.
Timepoint [2] 305244 0
Directly following prostatectomy (post-surgery).
Secondary outcome [1] 344613 0
Rate of minimal residual disease (MRD) is assessed on pathological examination of prostatectomy specimen.
Timepoint [1] 344613 0
Assessed for all patients immediately post prostatectomy
Secondary outcome [2] 344614 0
Rate of organ-confined disease is assessed on pathological examination of prostatectomy specimen.
Timepoint [2] 344614 0
Assessed for all patients immediately post prostatectomy
Secondary outcome [3] 344615 0
Rate of specimen-confined disease is assessed on pathological examination of prostatectomy specimen. (This is related to positive margin rates and is a separate outcome from secondary outcome 2).
Timepoint [3] 344615 0
Assessed for all patients immediately post prostatectomy
Secondary outcome [4] 344616 0
Correlative molecular studies including FGFR pathway activation and AR pathway activation. This is an exploratory outcome. Assessed by immunohistochemistry.
Timepoint [4] 344616 0
Assessed for all patients immediately post prostatectomy
Secondary outcome [5] 347768 0
Rate of partial response (PR) is assessed on pathological examination of prostatectomy specimen.
Timepoint [5] 347768 0
Assessed for all patients immediately post prostatectomy

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
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of bony metastatic disease.

Prior systemic therapy for prostate cancer.

Previous local therapy for prostate cancer including prior external beam radiotherapy, brachytherapy, HIFU or cryotherapy.

Active hepatitis B or C infection

Known active AIDS (human immunodeficiency virus (HIV) infection) unless the subject has been on a stable anti-retroviral therapy regimen for the last 6 months or more, has had no opportunistic infections in the last 6 months, and has CD4 count >350

History or current evidence of endocrine alteration of calcium-phosphorus homeostasis

History or current evidence of calcification/mineralisation of soft tissue or internal organs, with the exception of lymph node calcification or asymptomatic arterial calcification.

History or current evidence of corneal disorder/keratopathy or retinal abnormality, confirmed by ophthalmologic examination.

Uncontrolled hypertension

Clinically significant cardiac disease

History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug.

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
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10418 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22104 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 299023 0
University
Name [1] 299023 0
Melbourne Urology Trust
Address [1] 299023 0
Department of Surgery, University of Melbourne,
5th Floor Clinical Sciences Building,
Royal Melbourne Hospital, Grattan Street,
Parkville, VIC 3050, Australia
Country [1] 299023 0
Australia
Funding source category [2] 302448 0
Commercial sector/Industry
Name [2] 302448 0
Janssen-Cilag Pty Ltd
Address [2] 302448 0
1-5 Khartoum Road
Macquarie Park, NSW 2113
Country [2] 302448 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health (The Royal Melbourne Hospital)
Address
The Royal Melbourne Hospital
300 Grattan Street
Parkville, VIC 3050, Australia
Country
Australia
Secondary sponsor category [1] 298273 0
None
Name [1] 298273 0
None
Address [1] 298273 0
None
Country [1] 298273 0
Other collaborator category [1] 280030 0
Individual
Name [1] 280030 0
Dr Ben Tran
Address [1] 280030 0
Epworth Hospital Freemasons
Suite 123, Level 1
320 Victoria Parade
East Melbourne, VIC 3002, Australia
Country [1] 280030 0
Australia
Other collaborator category [2] 280031 0
Individual
Name [2] 280031 0
Prof Anthony Costello
Address [2] 280031 0
Australian Prostate Cancer Research Centre Epworth
Level 2, 185 Hoddle Street, Richmond, VIC 3121, Australia
Country [2] 280031 0
Australia
Other collaborator category [3] 280032 0
Individual
Name [3] 280032 0
Prof Chris Hovens
Address [3] 280032 0
Department of Surgery, Royal Melbourne Hospital
Level 5, Clinical Sciences Building
Royal Parade, VIC 3050, Australia
Country [3] 280032 0
Australia
Other collaborator category [4] 280033 0
Individual
Name [4] 280033 0
Dr Andrew Ryan
Address [4] 280033 0
TissuPath Pty Ltd,
165 Burwood Rd, Hawthorn, VIC 3122, Australia
Country [4] 280033 0
Australia
Other collaborator category [5] 280034 0
Individual
Name [5] 280034 0
Dr Phil Dundee
Address [5] 280034 0
Division of Urology, Royal Melbourne Hospital
Level 3, Royal Melbourne Hospital,
Parkville, VIC 3050, Australia
Country [5] 280034 0
Australia
Other collaborator category [6] 280035 0
Individual
Name [6] 280035 0
Dr Angelyn Anton
Address [6] 280035 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville, VIC 3050, Australia
Country [6] 280035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299958 0
Melbourne Health Human Research Ethics Committee [EC00243]
Ethics committee address [1] 299958 0
The Royal Melbourne Hospital
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria
Ethics committee country [1] 299958 0
Australia
Date submitted for ethics approval [1] 299958 0
26/03/2018
Approval date [1] 299958 0
26/06/2018
Ethics approval number [1] 299958 0

Summary
Brief summary
This is an open label phase II trial of a combination of therapies targeting prostate cancer.

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.

Study details
All participants in this trial will be treated with two medications called Degarelix and Erdafitinib for a period of 3 months, followed by Degarelix alone for a further 1-month 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. Assessments include blood tests, eye examinations, heart examinations and vital signs.

We cannot guarantee or promise that participants will receive any benefits from this research; however, possible benefits may include further knowledge for treatment options for patients in the future with high risk prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82082 0
Dr Niall Corcoran
Address 82082 0
Department of Surgery, University of Melbourne,
5th Floor Clinical Sciences Building,
Royal Melbourne Hospital, Grattan Street,
Parkville, VIC 3050, Australia
Country 82082 0
Australia
Phone 82082 0
+61 03 93427294
Fax 82082 0
+61 03 93428928
Email 82082 0
niallmcorcoran@gmail.com
Contact person for public queries
Name 82083 0
Mr Nicholas Howard
Address 82083 0
Epworth Prostate Centre
Level 2, 185 Hoddle Street
Richmond, VIC 3121
Country 82083 0
Australia
Phone 82083 0
+61 03 99368032
Fax 82083 0
+61 03 94294952
Email 82083 0
nick.howard@hotmail.com
Contact person for scientific queries
Name 82084 0
Dr Niall Corcoran
Address 82084 0
Department of Surgery, University of Melbourne,
5th Floor Clinical Sciences Building,
Royal Melbourne Hospital, Grattan Street,
Parkville, VIC 3050, Australia
Country 82084 0
Australia
Phone 82084 0
+61 03 93427294
Fax 82084 0
+61 03 93428928
Email 82084 0
niallmcorcoran@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not approved by the reviewing HREC as part of the submission for this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results