NCT01344564

Brief Summary

The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

April 27, 2011

Last Update Submit

March 15, 2013

Conditions

Prostate Cancer

Keywords

Prostate cancerHormone therapyTestosterone measures

Outcome Measures

Primary Outcomes (1)

  • Testosterone measurement

    11 times over 6 months

Study Arms (1)

ADT

OTHER

All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.

Drug: Degarelix acetate, Leuprolide acetate

Interventions

Degarelix acetate, Leuprolide acetateDRUG

Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once

Also known as: Firmagon, Eligard
ADT

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Androgen deprivation therapy is indicated

You may not qualify if:

  • Baseline screening serum testosterone \<150ng/dL
  • Eastern Cooperative Oncology Group (ECOG) score \> 2
  • Diagnosed spinal or brain metastases
  • Hormonal manipulation within previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamideLeuprolideluprolide acetate gel depot

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Robert Given, MD

    Urology of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)