NCT02749825

Brief Summary

This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for phase_4 prostate-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_4 prostate-cancer

Geographic Reach
1 country

11 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

September 1, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
4 years until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 25, 2016

Status Verified

May 1, 2012

Enrollment Period

3.7 years

First QC Date

May 8, 2012

Last Update Submit

April 20, 2016

Conditions

Prostate Cancer

Keywords

ProstateCancerTrelstar

Outcome Measures

Primary Outcomes (1)

  • Maintenance of serum testosterone at or below castration level (50ng/dL)

    Primary efficacy

    12 weeks

Secondary Outcomes (3)

  • Serum testosterone level at end of study

    Week 12

  • Change in serum testosterone from baseline to end of study

    Baseline and week 12

  • Incidence and severity of adverse events

    12 weeks

Study Arms (3)

Trelstar

EXPERIMENTAL

Per prescribing information

Drug: Trelstar

Lupron

ACTIVE COMPARATOR

Per prescribing information

Drug: Lupron

Zoladex

ACTIVE COMPARATOR

Per prescribing information

Drug: Zoladex

Interventions

TrelstarDRUG

As labeled

Also known as: Triptorelin pamoate
Trelstar
LupronDRUG

As labeled

Also known as: luprolide acetate for depot suspension
Lupron
ZoladexDRUG

As labeled

Also known as: goserelin acetate
Zoladex

Eligibility Criteria

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

You may qualify if:

  • Advanced Prostate Cancer
  • Currently taking Lupron or Zoladex
  • Stable PSA
  • Baseline testosterone below castration level
  • Life expectancy \> 6 months
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Signed, approved informed consent.

You may not qualify if:

  • Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
  • Ongoing therapy with hyperprolactinemic agents
  • Antiandrogen therapy within 28 days prior to study start
  • Prior Orchiectomy, hypophysectomy or adrenalectomy
  • Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
  • Use of any investigational agent 3 months prior to enrollment
  • Use of systemic corticosteroids within 28 days or during study
  • Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
  • Severe kidney or liver failure, based on adequate lab values
  • Other medical conditions which would be likely to interfere with compliance or completion of study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Arizona Urologic Specialists

Tucson, Arizona, 85712-5803, United States

Location

Heritage Physician Group - Urology Department

Hot Springs, Arkansas, 71913, United States

Location

California Oncology of the Central Valley

Fresno, California, 93710, United States

Location

San Bernardino Urological Associates Medical Group

San Bernardino, California, 92404, United States

Location

UroSearch

Ocala, Florida, 34470, United States

Location

Scott A Slavis, MD, PC

Las Vegas, Nevada, 89109, United States

Location

Shaukat M Qureshi, MD

Pennsville, New Jersey, 08070, United States

Location

Brooklyn Heights Urology Associates

Brooklyn, New York, 11201, United States

Location

Jazrawi-Atallah, P.C.

Brooklyn, New York, 11201, United States

Location

Albemarle Urology Clinic, PA

Albemarle, North Carolina, 28001, United States

Location

Raj P. Chopra MD, PC

Bloomsburg, Pennsylvania, 17815, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

Triptorelin PamoateLeuprolideGoserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital 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

  • Michael Michael Manyak, MD

    Georege Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2012

First Posted

April 25, 2016

Study Start

September 1, 2002

Primary Completion

May 1, 2006

Study Completion

July 1, 2006

Last Updated

April 25, 2016

Record last verified: 2012-05

Data Sharing

IPD Sharing
Will not share

Locations

US(11)