Clinical trial NCT03701659: TUPKRP Combined With MAB Therapy for LUTS/PCa
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Prostate Cancer
Lower Urinary Tract Symptoms
Quality of Life
Overall Survival
Progression of Prostate Cancer
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Hormone sensibility advanced prostate adenocarcinoma, clinical stages are T3-4N0-1M0-1b；
2. International prostate symptom score is equal to or greater than 20;
3. Maximum flow rate is equal to or less than 10ml/s, or bladder outlet obstruction is diagnosed by urodynamics
4. Any of the following complication: ① calculus in bladder; ② Recurrent urinary tract infections; ③Inguinal hernia; ④vesicoureteral reflux
5. The physical status score of the Eastern Cancer Cooperative Group (ECOG) is 0 or 1;
6. There has been no previous evidence of malignancy in the past five years.
7. The patient is in good physical condition and able to tolerate anesthesia and surgery;
8. There are no allergic reactions and liver or kidney function damage to endocrine drugs;
9. Ability to take and retain medicines;
10. Ability to follow study visit schedules and other program requirements；
11. Be able to understand the character and purpose of the study, including possible risks and side effects; Be able to work with researchers and follow the requirements of the entire study;
12. Ability to sign and date informed of the full character and purpose of the study, including possible risks and side effects, and sufficient time and opportunity to read and understand the information about this study.

Exclusion Criteria:

1. Patients with castration-resistant prostate cancer;
2. The physical status score of East Cancer cooperative Group is equal to or greater than 2;
3. There has been previous evidence of other malignancy in the past five years;
4. Patients with high coagulation and cannot stop taking anticoagulants;
5. Abnormal coagulation function such as hemophilia;
6. The patients are in poor physical condition and cannot tolerate anesthesia and surgery;
7. The patients have allergy or toxic side effects and other adverse reaction to endocrine drug;
8. Patients with active tuberculosis or other fulminating infectious disease;
9. Patients with immunodeficiency;
10. Patients with the lower limb and joint function abnormality, cannot maintain the lithotomy position for a long time;
11. Patients with urethral stricture;
12. Unable to comply with study visit schedule and other program requirements;
13. Any patients, who are regarded cannot not participate in the study;

Primary outcomes:
measure: PSA
timeFrame: 3 months
measure: Maximum flow rate
timeFrame: 3 months
measure: IPSS
timeFrame: 3 months
measure: QoL
timeFrame: 3 months
measure: ECOG
timeFrame: 3 months
measure: MRI
timeFrame: 6 months
measure: SPECT
timeFrame: 6 months
measure: PVR
timeFrame: 3 months
measure: OS
timeFrame: 12 months
measure: PFS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Zhijun Huang, MD
role: STUDY_DIRECTOR
References: