NCT01512472

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

6 years

First QC Date

November 10, 2011

Last Update Submit

September 19, 2019

Conditions

Prostate Cancer Recurrent

Keywords

localized prostate cancerdegarelixintermittent androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    approximately 15 months

Secondary Outcomes (1)

  • serum PSA

    at 4 months (4 mon arm) or 10 montths (10 mon arm)

Study Arms (2)

10 month degarelix therapy

ACTIVE COMPARATOR
Drug: degarelix

4 month degarelix therapy arm

ACTIVE COMPARATOR
Drug: degarelix

Interventions

degarelixDRUG

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.

10 month degarelix therapy4 month degarelix therapy arm

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

The Prostate Centre

Vancouver, British Columbia, V6Z 3J5, Canada

Location

Manitoba Prostate Centre

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Centre of Clinical Research

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Northeast Cancer Centre, Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

McMaster Institute of Urology

Hamilton, Ontario, L8N 4A6, Canada

Location

Centre of Applied Urological Research / Kingston General Hospital

Kingston, Ontario, K7L 3J7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

URLX Corporation

Ottawa, Ontario, K1H 1A2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Recherches Clinique /Clinical Research

Granby, Quebec, J2G 8Z9, Canada

Location

The Urology Specialists / Les Urologues Specialises

Montreal, Quebec, H2X 1N8, Canada

Location

MUHC Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Ultra-Med Research

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Centre de recherche du CHUQ-L'hotel-Dieu de Quebec

Québec, Quebec, G1R 3S1, Canada

Location

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Study Officials

  • Laurence Klotz, MD

    Canadian Urology Research Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

CA(15)