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Hormone Therapy

Dutasteride, Bicalutamide, Tamoxifen for Lower Urinary Tract Symptoms

Phase 2

Waitlist Available

Led By Andre-Guy Martin, MD

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

The purpose of this study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.

Eligible Conditions

Lower Urinary Tract Symptoms
Prostate Cancer
Erectile Dysfunction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks pre-implant, pre-implant, 6 weeks post-implant, 3,6,12,18 and 24 months post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total prostate volume

Secondary study objectives

Abnormal liver function tests

Acute urinary retention rates

Adverse events recording

+10 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dutasteride, Bicalutamide, TamoxifenExperimental Treatment1 Intervention

Administration of Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure. Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.

Group II: LHRH agonistActive Control1 Intervention

Administration of a 3-month treatment with an LHRH agonist (chosen by the treating radiation oncologist) and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bicalutamide

FDA approved

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