HoLEP Before Radiation Therapy for Prostate Cancer

(HOLEP-RTPC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Bristol Whiles, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kansas Medical Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Bladder cancer, Prior prostate treatment, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

How does the HoLEP treatment differ from other treatments for prostate cancer?

HoLEP (Holmium Laser Enucleation of the Prostate) is unique because it uses a laser to remove prostate tissue, which can help relieve urinary symptoms before radiation therapy. This approach is different from standard treatments like external beam radiation therapy or hormone therapy, which focus on controlling cancer growth rather than addressing urinary obstruction directly. ^{1 2 3 4 5}

Research Team

Bristol Whiles, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Holmium Laser Enucleation of Prostate (HoLEP) (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

Findings from Research

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Management strategies for locally advanced prostate cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Carcinoma of the prostate: local control with external beam radiation therapy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer. [2015]

4. Spain pubmed.ncbi.nlm.nih.gov

[Current treatment in high risk and locally advanced prostate cancer]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Selecting initial therapy for prostate cancer. Radiation therapy perspective. [2019]