NCT01545882

Brief Summary

This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy. The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

March 1, 2012

Last Update Submit

May 5, 2020

Conditions

Prostatic Neoplasms

Keywords

prostatehormone-resistantdegarelixfirmagonanti-androgenstotal androgen blockadeinjection

Outcome Measures

Primary Outcomes (1)

  • PSA Progression

    Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

    Monthly for 6 months then every 3 months

Secondary Outcomes (3)

  • Time to Disease progression

    Monthly for 6 months then every 3 months

  • The efficacy of Testosterone, LH and FSH suppression with Degarelix

    Monthly for 6 months then every 3 months

  • The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer

    Month 3 and 6 then every 3 months

Study Arms (1)

Degarelix

EXPERIMENTAL

Degarelix treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Drug: Degarelix

Interventions

DegarelixDRUG

Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Also known as: Firmagon
Degarelix

Eligibility Criteria

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

You may qualify if:

  • Prior trial of total androgen blockade
  • Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
  • Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
  • ECOG ≤ 2
  • Age ≥ 18 years
  • Serum testosterone of ≤ 50 mg/dl
  • PSA ≥ 2.0 ng/ml
  • White blood cell count ≥ 3000/mm3
  • Platelets ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 x upper limits of normal
  • Bilirubin ≤ 1.5 x upper limits of normal
  • Alanine transaminase ≤ 1.25 x upper limits of normal
  • Estimated life expectancy of at least 12 months
  • Able and willing to sign informed consent

You may not qualify if:

  • Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
  • Known allergy to GnRH agonists or antagonists
  • Previous treatment with Degarelix
  • Major surgery within 4 weeks of registration
  • Grade ≥ 3 peripheral neuropathy
  • Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
  • Acute deep vein thrombosis or pulmonary embolism
  • Taking anti-arrhythmia medication
  • Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
  • Prior orchiectomy for prostate cancer
  • PSA \> 100 ng/mL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H8L6, Canada

Location

Princess Margeret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Shawn Malone, Dr.

    The Ottawa Hospital Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

July 1, 2013

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations

CA(3)