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Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer

NCT01656161•Debiopharm International SA

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: * achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and * in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Eligibility

Age

All ages

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Meets protocol-specified criteria for qualification and contraception
•Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
•Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

•Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
•Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Locations (10)

Paarl Medical Centre

Paarl, Cape Town, Western Cape, South Africa

Vergelegen Medi-Clinic

Somerset West, Cape Town, South Africa

Department of Urology, Tygerberg Hospital

Tygerberg, Cape Town, South Africa

JCM Bahlmann

George, Eastern Cape, South Africa

East Rand Urology Research Unit, Clinix Private Clinic

Johannesburg, Gautang, South Africa

Clinresco Centres (Pty) Ltd

Kempton Park, Gauteng, South Africa

Clinical Trial Unit, Room 2-54, Prinshof Medical Campus

Pretoria, Gauteng, South Africa

Pretoria Urology Hospital

Pretoria, Gauteng, South Africa

Wilmed Park Hospital

Klerksdorp, North West, South Africa

New Groote Schuur Hospital, Division of Urology

Cape Town, South Africa

Key Dates

Start Date

July 1, 2012

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

September 15, 2015

Enrollment

120

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Triptorelin embonate 22.5 mg

DRUG

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC