Holmium Laser Enucleation of the Prostate for the Alleviation of Lower Urinary Tract Symptoms in Patients with Prostate Cancer

Status: active

This clinical trial evaluates holmium laser enucleation of the prostate (HoLEP) for the alleviation of lower urinary tract symptoms (LUTS) in patients with prostate cancer, and determines whether or not HoLEP alters the treatment course in these patients. Prostate cancer patients often suffer from LUTS, which can have negative impacts on their quality of life. HoLEP is a minimally invasive surgical procedure by which obstructive tissue is removed from the prostate. It has been approved for use in men with LUTS, but it hasn't been well studied in those who also have prostate cancer. HoLEP may help improve LUTS in men with prostate cancer.

Inclusion Criteria

Patients must be 18 years of age or older
Patients must have bothersome LUTS, meeting one of the following criteria: * Using an Urological Association Symptom Score (AUA SS) of >= 12; * Urinary retention defined as a post-void residual of >= 350 mL * Catheter dependence * Bladder outlet obstruction on urodynamics
Patients must be diagnosed with prostate cancer by pathologic tissue analysis
Patients must have elected for radiation or radiation with androgen deprivation therapy or active surveillance as the primary treatment modality for their prostate cancer

Exclusion Criteria

Patients who are under 18 years of age are not eligible
Patients who have a diagnosis of bladder cancer are not eligible
Patients with prior treatment for prostate cancer are not eligible
Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate are ineligible. Prior prostate biopsy is acceptable
Patients with known metastatic prostate cancer
Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible

PRIMARY OBJECTIVES:

I. To determine if HoLEP improves patient qualify of life in those with concurrent prostate cancer as well as determine if such improvement is sustained after completion of radiation therapy (only when applicable and when radiotherapy is completed) with assessment at:

Ia. 1 year post-operatively.

Ib. 5 years post-operatively.

SECONDARY OBJECTIVE:

I. To determine if HoLEP alters the prostate cancer treatment course in patients with LUTS and/or urinary retention and known prostate cancer (i.e. Do some patients not need radiation therapy; is HoLEP a possible treatment modality for prostate cancer?).

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM I: Patients who plan to undergo standard of care radiation therapy undergo HoLEP.

ARM II: Patients who plan to undergo standard of care radiation therapy receive no intervention.

ARM III: Patients undergoing active surveillance for their prostate cancer undergo HoLEP.

After completion of study treatment, patients are followed up every 3 months for 1 year and then annually for 5 years.

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Holmium Laser Enucleation of the Prostate for the Alleviation of Lower Urinary Tract Symptoms in Patients with Prostate Cancer

Inclusion Criteria

Exclusion Criteria

United States

Kansas

Kansas City

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Holmium Laser Enucleation of the Prostate for the Alleviation of Lower Urinary Tract Symptoms in Patients with Prostate Cancer

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