NCT03701659

TUPKRP Combined With MAB Therapy for LUTS/PCa

A Prospective, Multi-center Clinical Study of Palliative Transurethral Plasma Kinetic Resection of Prostate (TUPKRP) Combined With Endocrine Therapy for Advanced Prostate Cancer Complicated With Severe Lower Urinary Tract Symptoms

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: Male
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide, accounting for 15% of all male cancers. In 2015, there were 220,800 estimated new cases of prostate cancer and 27,540 deaths by PCa, making this disease the second leading cause of cancer-related death for North American men. Men with PCa may develop lower urinary tract symptoms (LUTS) when prostate tumors invade or compress the prostatic urethra, the bladder or the neurovascular bundles, or when the prostate is enlarged. It has been estimated that over 40% of men with PCa experience moderate or severe LUTS. LUTS can impact profoundly on a man's quality of life (QoL); an effect that increases with increasing LUTS severity. Transurethral resection of prostate (TURP) can offer immediate relief of the obstruction in patients with benign prostatic hyperplasia (BPH). In contrast, palliative TURP (p-TURP) (the so-called "channel" TURP), is transurethral resection of prostate tissue in a patient with metastatic or locally advanced and/or previously treated PCa to alleviate obstructive voiding symptoms. Al¬though TURP is commonly performed to relieve bladder outlet ob¬struction (BOO) symptoms in patients with BPH, little known about the outcome of palliative transurethral plasma kinetic resection of prostate (p-TUPKRP) in patients with ad-vanced PCa. Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy (ADT) are the standard treatment for many patients with PCa, particularly those with advanced or metastatic disease. The impact of ADT on tumor control and achieving the reduction in prostate specific antigen (PSA) is well established. But there is less information available on the effects on LUTSs in men with PCa. Some short-term studies of ADT with the GnRH antagonist or with ADT in the neoadjuvant setting have demonstrated reductions in LUTSs, measured by the International Prostate Symptom Score (IPSS). There are few published data on the longer-term effects of ADT on LUTSs, apart from an earlier interim analysis of data from the current study. In this study, p-TUPKRP combined with ADT will perform for 50 patients with advanced PCa complicated with severe LUTS. As a control, other 50 advanced PCa patients with same symptoms will be treated with ADT only. Some clinical data, including PSA, IPSS, QoL, Urinary flow rate (UFR), ECOG Score, Overall survival (OS), progression-free survival (PFS), will be analyzed. It is expected to explore the efficacy and safety of the combination therapy to advanced PCa with severe LUTS.

Conditions

• Advanced Prostate Cancer
• Lower Urinary Tract Symptoms
• Quality of Life
• Overall Survival
• Progression of Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgery combinate with Endocrine therapy	TUPKRP is abbreviation of transurethral plasma kinetic resection of prostate, which is an effective treatment of bladder outlet obstruction for benign prostate hyperplasia. MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrinotherapy for advanced prostate cancer.
DRUG	Endocrine therapy	MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrine therapy for advanced prostate cancer.

Timeline

• Start date: 2018-12-01
• Primary completion: 2023-11-30
• Completion: 2025-11-30
• First posted: 2018-10-10
• Last updated: 2018-10-10