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Procedure

HoLEP Before Radiation Therapy for Prostate Cancer (HOLEP-RTPC Trial)

N/A

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence

Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prostate cancer treatment course will assessed five years post-operatively

Awards & highlights

HOLEP-RTPC Trial Summary

This trial is testing whether HoLEP alters the treatment course for patients with both LUTS/urinary retention and prostate cancer.

Who is the study for?

This trial is for men over 18 with bothersome urinary symptoms or who can't fully empty their bladder, and have prostate cancer confirmed by tissue analysis. They must be planning to undergo radiation and hormone therapy but haven't had any prior treatment for prostate cancer, including surgery.Check my eligibility

What is being tested?

The study tests if using a laser technique called HoLEP to relieve urinary symptoms affects the course of treatment in patients who also have prostate cancer and are opting for radiation and hormone therapy.See study design

What are the potential side effects?

Possible side effects of HoLEP include discomfort during urination, blood in urine, urgent need to urinate, urinary tract infection, temporary difficulty controlling urine flow (incontinence), or erectile dysfunction.

HOLEP-RTPC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have significant urinary problems as measured by specific medical criteria.

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I chose radiation and hormone therapy as my main prostate cancer treatment.

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My prostate cancer diagnosis was confirmed through a tissue test.

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I am 18 years old or older.

HOLEP-RTPC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ quality of life will be assessed five years post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~quality of life will be assessed five years post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and quality of life will be assessed five years post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in Quality of Life - Five Years Post Operatively

Improvement in Quality of Life - One Year Post Operatively

Secondary outcome measures

Prostate Cancer Treatment Course - Five Years Post Operatively

Prostate Cancer Treatment Course - One Year Post Operatively

HOLEP-RTPC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Holmium Laser Enucleation of Prostate (HoLEP)Experimental Treatment1 Intervention

Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.

Group II: Control ArmActive Control1 Intervention

Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,239 Total Patients Enrolled

10 Trials studying Prostate Cancer

587 Patients Enrolled for Prostate Cancer

Media Library

Holmium Laser Enucleation of Prostate (HoLEP) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03802851 — N/A

Prostate Cancer Research Study Groups: Holmium Laser Enucleation of Prostate (HoLEP), Control Arm

Prostate Cancer Clinical Trial 2023: Holmium Laser Enucleation of Prostate (HoLEP) Highlights & Side Effects. Trial Name: NCT03802851 — N/A

Holmium Laser Enucleation of Prostate (HoLEP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03802851 — N/A

Frequently Asked Questions

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

Does this research endeavor currently have capacity for participants?

"Affirmative, clinicaltrials.gov reveals that this trial is actively recruiting patients. The project was originally made public on September 19th 2019 and the most recent edit took place on November 15th 2022. This medical experiment requires 30 participants at a single site to be enrolled."

Answered by AI

How many participants have been included in this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is currently accepting participants - first posted on September 19th 2019 and most recently revised on November 15th 2022. With a single site available for enrollment, 30 patients are needed in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

2019. "HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03802851.

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