30 Participants Needed

HoLEP Before Radiation Therapy for Prostate Cancer

(HOLEP-RTPC Trial)

AD
JL
Overseen ByJane Ledesma, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

BW

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Holmium Laser Enucleation of Prostate (HoLEP)Experimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

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

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Approved in United States as HoLEP for:
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Approved in European Union as HoLEP for:
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Approved in Canada as HoLEP for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Published Research Related to This Trial

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

Citations

Management strategies for locally advanced prostate cancer. [2018]
Carcinoma of the prostate: local control with external beam radiation therapy. [2019]
Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer. [2015]
[Current treatment in high risk and locally advanced prostate cancer]. [2019]
Selecting initial therapy for prostate cancer. Radiation therapy perspective. [2019]
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