HoLEP Before Radiation Therapy for Prostate Cancer

(HOLEP-RTPC Trial)

Overseen By Jane Ledesma, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Bladder cancer, Prior prostate treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if holmium laser enucleation of the prostate (HoLEP) can alter the treatment plan for men with prostate cancer who also experience urinary issues. HoLEP is a laser treatment designed to alleviate lower urinary tract symptoms, such as difficulty urinating or the sensation of an incomplete bladder emptying. The trial will include two groups: one will receive HoLEP, while the other will follow the usual care plan without additional treatment. Men with prostate cancer and bothersome urinary problems may qualify for this trial if they have chosen radiation and hormone therapy as their primary cancer treatment. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options for managing urinary symptoms alongside their cancer therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that HoLEP is safe for treating lower urinary tract symptoms?

Research has shown that using a holmium laser to treat prostate problems (HoLEP) is generally safe for patients. Studies have found that HoLEP is well-tolerated by individuals with prostate cancer and urinary issues. Patients undergoing this treatment often experience fewer complications compared to traditional methods.

HoLEP has demonstrated results similar to other common procedures for enlarged prostate, such as transurethral resection of the prostate (TURP) and open prostate surgery. These findings suggest that HoLEP is a reliable option for treating urinary symptoms in men with prostate issues, with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Holmium Laser Enucleation of the Prostate (HoLEP) before radiation therapy for prostate cancer because it offers a unique approach to managing lower urinary tract symptoms (LUTS). Unlike standard treatments, which might rely on medications or traditional surgical methods, HoLEP uses a laser to precisely remove prostate tissue, potentially leading to quicker recovery and less bleeding. This technique can improve urinary flow and reduce symptoms more effectively and with fewer side effects. By addressing LUTS before radiation, researchers hope to enhance the overall treatment experience and outcomes for patients with prostate cancer.

What evidence suggests that HoLEP might be an effective treatment for lower urinary tract symptoms in prostate cancer patients?

Research has shown that using a holmium laser to treat an enlarged prostate, known as HoLEP, effectively relieves urinary problems and difficulty urinating. Studies have found that HoLEP provides excellent symptom relief with few complications. It performs as well as traditional surgeries like TURP (transurethral resection of the prostate) and open prostate surgery. In this trial, some participants will undergo HoLEP to address lower urinary tract symptoms. Additionally, HoLEP might reduce the need for future prostate cancer treatments in patients with both urinary issues and prostate cancer. Overall, HoLEP is a safe and effective method for treating urinary symptoms caused by an enlarged prostate. ^{2 3 4 5 6}

Who Is on the Research Team?

Bristol Whiles, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

My prostate cancer diagnosis was confirmed through a tissue test.

Exclusion Criteria

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

I do not have metastatic prostate cancer.

I do not have bladder cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for quality of life and prostate cancer treatment course post-operatively

5 years

Regular follow-up visits as per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• Holmium Laser Enucleation of Prostate (HoLEP)

Trial Overview 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.

How Is the Trial Designed?

Group I: Holmium Laser Enucleation of Prostate (HoLEP) Experimental Treatment 1 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 Arm Active Control 1 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.

Holmium Laser Enucleation of Prostate (HoLEP) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)
• Urinary Retention

Approved in European Union as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)
• Urinary Retention

Approved in Canada as HoLEP for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)
• Urinary Retention

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

A review of 51 studies on locally advanced prostate cancer indicates that combined therapy with radiotherapy (RT) and hormonotherapy (HT) can provide significant benefits for patients.

Radical prostatectomy (RP) may also be effective in selected cases, with long-term outcomes comparable to those of RT and HT, suggesting that RP remains a viable treatment option despite ongoing controversies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current treatment in high risk and locally advanced prostate cancer]. Esquena Fernández, S., Maroto Rey, P., Sancho Pardo, G., et al.[2019]

In a study of 209 patients with stage C adenocarcinoma of the prostate treated with external beam radiation therapy, 92% did not require further operations for urinary obstruction, indicating effective local control of the disease.

After treatment, 83% of patients reported no urinary complaints, and the incidence of complications like hematuria and incontinence was significantly lower than in non-irradiated patients, suggesting that external beam radiation therapy is a safe and effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinoma of the prostate: local control with external beam radiation therapy. Gibbons, RP., Mason, JT., Correa, RJ., et al.[2019]

The standard treatment for locally advanced prostate cancer involves photon external beam radiotherapy (EBRT) combined with long-term androgen ablation, which has been shown to improve outcomes compared to short-term ablation.

Current research is focused on optimizing treatment strategies, including the sequencing of hormone therapy with radiotherapy and exploring new techniques like intensity-modulated radiotherapy to enhance efficacy while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management strategies for locally advanced prostate cancer. Jani, AB.[2018]

Neoadjuvant systemic therapy, particularly with docetaxel, is a promising approach for men with high-risk localized prostate cancer, showing feasibility and safety before radical prostatectomy (RP).

While no studies have yet confirmed the efficacy of neoadjuvant chemotherapy or chemohormonal therapies, ongoing research is exploring novel agents that target various growth factor receptors and immunomodulatory treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer. Cha, EK., Eastham, JA.[2015]

External-beam radiation therapy for prostate cancer has been studied since 1956 at Stanford, focusing on its potential to cure the disease and the effectiveness of different techniques.

The report highlights the importance of patient selection for radiation therapy, comparing its outcomes and suitability against surgical options for treating prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting initial therapy for prostate cancer. Radiation therapy perspective. Bagshaw, MA., Ray, GR., Cox, RS.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34694647/

Long-term outcomes of Holmium laser enucleation ... We aimed to evaluate long-term outcomes, symptom recurrence rate, and predictors in patients that underwent HoLEP.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666168325002794

Outcomes of Active Treatment for Localised Prostate ... Among urological lasers, holmium laser is the most useful one because it can treat urinary stones, strictures, and prostatic tissue, and flexible fibres are ...

3. icurology.org icurology.org/DOIx.php?id=10.4111/icu.20240080

Clinical outcomes of holmium laser enucleation of the ... In conclusion, our midterm follow-up results after HoLEP in patients with BPH showed excellent efficacy and low complication rates. Unlike ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04391114

Top-Down Holmium Laser Enucleation of the Prostate ... HoLEP is a safe and effective procedure which has demonstrated comparable results to TURP and open prostatectomy for patients with symptomatic enlarged prostate ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pros.24906

Impact of Holmium Laser Enucleation of the Prostate on ... Conclusion. Performing HoLEP in patients under AS for PCa with LUTS due to BPH may reduce the risk of deferred prostate cancer treatment, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24147796/

Holmium laser enucleation of the prostate is safe in ... Holmium laser enucleation of the prostate is safe in patients with prostate cancer and lower urinary tract symptoms--a retrospective feasibility study · Abstract.