What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly minimally invasive procedures like HoLEP, include robotic-assisted radical prostatectomy (RARP) and other laser-based surgeries. The side effects of these treatments can include urinary incontinence, sexual dysfunction, and bowel symptoms. Specifically, RARP may result in urinary incontinence and erectile dysfunction, although these effects can vary in severity and duration. Bowel symptoms are less common but can occur, especially with treatments involving radiation. Overall, minimally invasive techniques tend to have fewer perioperative complications, such as reduced blood loss and shorter hospital stays, compared to open surgeries.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including systemic therapies like androgen deprivation therapy (ADT), androgen receptor signaling inhibitors (e.g., enzalutamide, abiraterone), and radioligand therapies (e.g., lutetium Lu 177 vipivotide tetraxetan). While the context does not specify FDA approvals for treatments exactly like Holmium Laser Enucleation of the Prostate (HoLEP), which is a minimally invasive procedure to remove obstructive prostate tissue, it is important to note that HoLEP itself is a well-established surgical technique for benign prostatic hyperplasia (BPH) and may be used in patients with concurrent prostate cancer to alleviate urinary symptoms.

What other types of research exist?

Promising novel alternatives to HoLEP for prostate cancer patients considering treatment in 2024 include Prostatic Artery Embolization (PAE) and various transurethral procedures such as bipolar transurethral resection of the prostate (TURP) and transurethral water vapor ablation. These methods offer minimally invasive options with encouraging outcomes for managing LUTS and urinary retention.

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Procedure

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

N/A

Recruiting

Led By Bristol Whiles, MD

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

Must not have

Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible

Patients with known metastatic prostate cancer are ineligible

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using a laser procedure to remove extra prostate tissue can help men with urinary problems and prostate cancer who are planning to get radiation therapy. The goal is to see if this procedure can make it easier to urinate and possibly reduce the need for more radiation. Laser treatment has evolved to significantly reduce blood loss compared to traditional methods.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any prostate surgery except for a biopsy.

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I do not have metastatic prostate cancer.

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I do not have bladder cancer.

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I have not received any treatment for prostate cancer before.

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I am 18 years old or older.

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

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

Primary study objectives

Improvement in Quality of Life - Five Years Post Operatively

Improvement in Quality of Life - One Year Post Operatively

Secondary study objectives

Prostate Cancer Treatment Course - Five Years Post Operatively

Prostate Cancer Treatment Course - One Year Post Operatively

Awards & Highlights

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: 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 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments work through various mechanisms to target and eliminate cancerous cells. Surgical options like Holmium Laser Enucleation of the Prostate (HoLEP) involve the minimally invasive removal of obstructive prostate tissue, which can alleviate symptoms and improve urinary flow. Radiation therapy uses high-energy rays to destroy cancer cells, while androgen deprivation therapy (ADT) reduces levels of male hormones that can fuel cancer growth. These treatments are crucial for prostate cancer patients as they can significantly reduce tumor size, alleviate symptoms, and improve quality of life, while also potentially extending survival.

The male lumpectomy: rationale for a cancer targeted approach for prostate cryoablation. A review.