NCT01630967

Brief Summary

Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

June 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

June 25, 2012

Last Update Submit

June 27, 2012

Conditions

Prostate Neoplasm

Keywords

castrate resistancePSA progressionLHRH antagonism

Outcome Measures

Primary Outcomes (1)

  • 50% fall in PSA

    Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist

    8 weekly

Secondary Outcomes (7)

  • Luteinizing hormone (LH)

    8 weekly

  • Follicle stimulating hormone (FSH)

    8 weekly

  • Testosterone (TT)

    8 weekly

  • dehydroepiandrosterone (DHEA)

    8 weekly

  • dehydroepiandrosterone-sulfate (DHEA-S)

    8 weekly

  • +2 more secondary outcomes

Study Arms (1)

Degarelix

EXPERIMENTAL

Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.

Drug: Degarelix

Interventions

DegarelixDRUG

Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.

Also known as: Firmagon
Degarelix

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed adenocarcinoma of the prostate
  • currently receiving LHRH agonist
  • Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
  • PSA \> 2 ng/ml
  • rising PSA despite LHRH agonist
  • patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
  • Prior chemotherapy allowed
  • ECOG performance status 0-1

You may not qualify if:

  • Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
  • Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

Related Publications (1)

  • Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.

    PMID: 21788033RESULT

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

  • Kim N Chi, MD

    British Columbia Cancer Agency, Univeristy of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim N Chi, MD

CONTACT

+1 604 877 6000kim.chi@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, University of British Columbia

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 28, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

CA(1)