Initiation of Androgen Deprivation Therapy for Prostate C... | NCT01344564

Studies
Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide

NCT01344564

Sponsor

Urology of Virginia

Status

Completed

Last Update Posted

Mar 18, 2013Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Degarelix acetate, Leuprolide acetate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Apr 27, 2011

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2013

Last Update Posted Date

Mar 18, 2013Estimated

Name	Class
Ferring Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADT	Other	All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.	Drug: Degarelix acetate, Leuprolide acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Degarelix acetate, Leuprolide acetate	Drug	Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once	ADT

Measure	Description	Time Frame
Testosterone measurement		11 times over 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Given, MD	Urology of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology of Virginia		Virginia Beach	Virginia	23462	United States

Type	Date	Date Unknown
Release	Sep 29, 2021
Reset	Oct 28, 2021

Submission Tracking

Estimated Results First Submitted Date

Sep 29, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 29, 2021			Oct 28, 2021

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C431566	acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide
D016729	Leuprolide
C493311	luprolide acetate gel depot

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided