Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Benign Prostatic Hyperplasia (BPH); Prostate Cancer

Treatments: Device: Prostatic Urethral Lift (PUL)

Study type: Interventional

Funder types: Other

Identifiers

NCT03817216

CASE10818

Details and patient eligibility

About

The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms.

Full description

Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy. The primary objective of this study is to achieve urinary obstructive symptom relief in prostate cancer participants undergoing radiotherapy treatment with placement of PUL. This will be quantified using primary effectiveness endpoints:

• For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
• For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy (BT) from pre-PUL baseline.

The team will also assess participant outcomes with regard to International Prostate Symptom Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores, Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External Beam Radiotherapy (EBRT), post-BT, and pre-BT.

Sex: Male

Ages: 51+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• International Prostate Symptom Score ≥ 12.
• Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
• Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).

Exclusion criteria

• Obstructive median lobe of the prostate.
• Active urinary tract infection.
• Neurogenic non-obstructive voiding dysfunction.
• Obstructive symptoms secondary to prostate cancer (via cystoscopy).
• Patients with prior Transurethral resection of the prostate (TURP).
• Patients with prior history of urethral stricture.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Prostatic Urethral Lift (PUL) post-EBRT

Experimental group

Description:

Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)

Treatment:

Device: Prostatic Urethral Lift (PUL)

Prostatic Urethral Lift (PUL) pre-BT

Experimental group

Description:

Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)

Treatment:

Device: Prostatic Urethral Lift (PUL)

Prostatic Urethral Lift (PUL) post-BT

Active Comparator group

Description:

Prostatic Urethral Lift (PUL) following Brachytherapy (BT)

Treatment:

Device: Prostatic Urethral Lift (PUL)