Phase 2 N=13 Randomized Triple-blind Treatment

Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00668642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle. — 0.24; 0.28 Relative expression

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dutasteride (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Endeavor Health
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.	0.24; 0.28	—
SECONDARY Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle	1.42; 1.56	—

Summary

The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

Eligibility Criteria

Inclusion Criteria

Histologically proven prostate cancer
Patients are hormone-naive
Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
Must have an intact prostate (no previous surgery or XRT)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Recovery from any major infection or surgical procedure
Signed informed consent

Exclusion Criteria

Known intolerance or allergy to dutasteride
Concomitant chemotherapy, biologic therapy, or XRT to prostate
Bilateral orchiectomy
Prior malignancy within 5 years of registration

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00668642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.