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Firmagon (Degarelix) Intermittent Therapy (FIT)

Primary Purpose

Prostate Cancer Recurrent

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
degarelix
Sponsored by
Canadian Urology Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Recurrent focused on measuring localized prostate cancer, degarelix, intermittent androgen deprivation therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
  • PSA level meeting both of these criteria:
  • PSA level of ≥ 5 ng/mL.
  • For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.
  • screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.

Exclusion Criteria:

  • Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
  • Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening

Sites / Locations

  • The Prostate Centre
  • Manitoba Prostate Centre
  • Centre of Clinical Research
  • McMaster Institute of Urology
  • Centre of Applied Urological Research / Kingston General Hospital
  • London Health Sciences Centre
  • URLX Corporation
  • Northeast Cancer Centre, Health Sciences North
  • Sunnybrook Health Sciences Centre
  • University Health Network
  • Recherches Clinique /Clinical Research
  • The Urology Specialists / Les Urologues Specialises
  • MUHC Montreal General Hospital
  • Ultra-Med Research
  • Centre de recherche du CHUQ-L'hotel-Dieu de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10 month degarelix therapy

4 month degarelix therapy arm

Arm Description

Outcomes

Primary Outcome Measures

serum PSA
The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml

Secondary Outcome Measures

serum PSA
PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.

Full Information

First Posted
November 10, 2011
Last Updated
September 19, 2019
Sponsor
Canadian Urology Research Consortium
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01512472
Brief Title
Firmagon (Degarelix) Intermittent Therapy
Acronym
FIT
Official Title
Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
acrrual target was not being met
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Urology Research Consortium
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.
Detailed Description
This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Recurrent
Keywords
localized prostate cancer, degarelix, intermittent androgen deprivation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 month degarelix therapy
Arm Type
Active Comparator
Arm Title
4 month degarelix therapy arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
degarelix
Intervention Description
Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.
Primary Outcome Measure Information:
Title
serum PSA
Description
The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml
Time Frame
approximately 15 months
Secondary Outcome Measure Information:
Title
serum PSA
Description
PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.
Time Frame
at 4 months (4 mon arm) or 10 montths (10 mon arm)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated PSA level meeting both of these criteria: PSA level of ≥ 5 ng/mL. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir. screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL. Exclusion Criteria: Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation) Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Klotz, MD
Organizational Affiliation
Canadian Urology Research Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prostate Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 3J5
Country
Canada
Facility Name
Manitoba Prostate Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Centre of Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
McMaster Institute of Urology
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Centre of Applied Urological Research / Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
URLX Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
Facility Name
Northeast Cancer Centre, Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Recherches Clinique /Clinical Research
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
The Urology Specialists / Les Urologues Specialises
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
MUHC Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Ultra-Med Research
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Centre de recherche du CHUQ-L'hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada

12. IPD Sharing Statement

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Firmagon (Degarelix) Intermittent Therapy

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