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5-alpha Reductase Inhibitor

Enzalutamide and dutasteride or finasteride for Prostate Cancer

Phase 2
Waitlist Available
Led By Chunkit Fung, M.D.
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to approximately 36 months
Awards & highlights

Study Summary

This trial will look at whether enzalutamide and dutasteride can delay the time to an increase in prostatic-specific antigen (PSA) levels in older patients.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA Progression Free Survival
Secondary outcome measures
Change in lowest PSA level compared to baseline PSA level (Absolute PSA response)
Number of participants who experience a treatment-related adverse events.
Time to PSA Nadir
Other outcome measures
Change in bone density
Comprehensive geriatric assessment domains
mean quality of life

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enzalutamide and dutasteride or finasterideExperimental Treatment1 Intervention
Use of either 1. Enzalutamide and dutasteride or 2. Enzalutamide and finasteride.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide and Dutasteride or finasteride
2014
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
836 Previous Clinical Trials
518,050 Total Patients Enrolled
7 Trials studying Prostate Cancer
514 Patients Enrolled for Prostate Cancer
Chunkit Fung, M.D.Principal InvestigatorUniversity of Rochester

Media Library

Dutasteride (5-alpha Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02213107 — Phase 2
Prostate Cancer Research Study Groups: Enzalutamide and dutasteride or finasteride
Prostate Cancer Clinical Trial 2023: Dutasteride Highlights & Side Effects. Trial Name: NCT02213107 — Phase 2
Dutasteride (5-alpha Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02213107 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing or completed research projects that have looked at Enzalutamide and Dutasteride?

"Enzalutamide and Dutasteride are being studied in 108 different clinical trials. Of those, 32 have progressed to Phase 3 testing. Most of the research is based out of Germantown, Tennessee; however, 5757 other locations across the globe are running similar trials."

Answered by AI

Has the FDA cleared Enzalutamide and Dutasteride for patient use?

"While there is some clinical data suggesting that Enzalutamide and Dutasteride are safe for use, efficacy has not been clinically proven. Consequently, our team scored this medication as a 2."

Answered by AI

Are we still looking for participants in this experiment?

"According to the information on clinicaltrials.gov, this particular study is not presently looking for participants. The trial was initially posted on 9/1/2014 and was most recently edited on 9/6/2022. Although this specific clinical trial is not recruiting patients anymore, there are 1475 other trials currently enrolling participants right now."

Answered by AI

Could I possibly qualify to take part in this clinical trial?

"Eligibility criteria for this study include being between 65-85 years old and having a diagnosis of prostate cancer. Around 40 individuals are needed for the trial."

Answered by AI

Could you explain the age limit for participants in this experiment?

"The study parameters indicate that only individuals aged 85 or below and 65 or above can qualify for the trial. Out of 1469 total clinical trials, 81 are specifically for patients under 18 years old."

Answered by AI

How many individuals are being tested in this clinical trial?

"Unfortunately, this study is not admitting any more patients at the moment. Although, it's worth noting that this trial was first posted on September 1st, 2014 and updated as recently as September 6th, 2022. There are presently 1367 studies actively admitting patients with prostate cancer and 108 trials for Enzalutamide and Dutasteride recruiting participants."

Answered by AI

What are Enzalutamide and Dutasteride typically prescribed to treat?

"Enzalutamide and Dutasteride can both effectively manage enlarged prostate, castration, and benign prostatic hyperplasia (bph)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.
Chunkit Fung 2014. "Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02213107.
~4 spots leftby Apr 2025
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