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Trial · Interventional

TerminatedPhase 4Registry data

Firmagon (Degarelix) Intermittent Therapy

Short name FIT

NCTNCT01512472 (opens ClinicalTrials.gov in a new tab)Other idCURC - FIT-0002
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
144 participants (actual)
Sponsor
Canadian Urology Research Consortium · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
Jan 2012
Primary completion
Jan 2018
Completion
Jan 2018
First posted
19 Jan 2012 (estimated)
Last update posted
23 Sept 2019
Conditions
Prostate Cancer Recurrent

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph 4

    FIT

    NCT01512472

    Jan 2012 to Jan 2018

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • degarelixDrug

Arms2

  • Active comparator

    10 month degarelix therapy

  • Active comparator

    4 month degarelix therapy arm

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. serum PSA

    Time frame · approximately 15 months

    Registry 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

Secondary outcomes(1)

  1. serum PSA

    Time frame · at 4 months (4 mon arm) or 10 montths (10 mon arm)

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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