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Firmagon (Degarelix) Intermittent Therapy

NCT01512472 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-09-23

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Recurrent

Interventions

DRUG

degarelix

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Canadian Urology Research Consortium

    lead OTHER

Principal Investigators

  • Laurence Klotz, MD · Canadian Urology Research Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512472 on ClinicalTrials.gov