CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Testosterone cypionate +2 moredrug
Likely dose
Testosterone cypionate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01750398
NCT01750398Phase 2Completed
CompareCT.gov

A Phase II Study of Bipolar Androgen-based Therapy for Men With Androgen Ablation NaÃ-ve Recurrent Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 17, 2012·Updated Dec 5, 2016

In Brief

A Phase 2 clinical trial evaluating Testosterone cypionate, Goserelin, and 1 other intervention for Recurrent Prostate Cancer. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and clinical effects of alternating androgen deprivation therapy with testosterone therapy in men with recurrent prostate cancer as first line hormonal therapy, to assess the effect of alternating therapy on quality of life and metabolic changes associated with androgen-deprivation therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.5 years ago

Interventions

Testosterone cypionatedrug

DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.

Goserelindrug

Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an "LHRH agonist."

Leuprolidedrug

Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.