Treatment for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UTSW, Dallas, TX
Prostate Cancer+1 More
Eligibility
18+
Male
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Study Summary

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Study Objectives

8 Primary · 5 Secondary · Reporting Duration: 3 years post-treatment

12 months post treatment
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting)
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting)
3 years post treatment
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting)
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting)
3 years post-treatment
Number of participants with adverse events or long-term complications (primary setting)
Number of participants with adverse events or long-term complications (salvage setting)
30 days post treatment
Number of participants with adverse events or short-term complications (primary setting)
Number of participants with adverse events or short-term complications (salvage setting)
Month 12
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting)
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting)
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting)
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

0 Treatment Group

225 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years post-treatment
Closest Location: UTSW · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
2017First Recorded Clinical Trial
1 TrialsResearching Prostate Cancer
5 CompletedClinical Trials

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
935 Previous Clinical Trials
594,175 Total Patients Enrolled
15 Trials studying Prostate Cancer
1,922 Patients Enrolled for Prostate Cancer
Xiaosong Meng, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent.
You have a life expectancy of at least 1 year.
You have histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.