Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Location contact
Dingwei Ye, MD.
CONTACT
Dingwei Ye, MD.
CONTACT
Xiaojian Qin, MD.
CONTACT
NCT Number: NCT06655259
This is a Phase II, open-label, prospective, single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients with metastatic prostate cancer (mPCa). All participants will undergo TURP to relieve urinary obstruction and reduce tumor burden, followed by androgen deprivation therapy (ADT) and second-generation anti-androgen agents, such as abiraterone or enzalutamide. The primary outcome is radiographic progression-free survival (rPFS), with secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), PSA response rates at 3 and 6 months, and quality of life assessments. The trial will enroll 200 newly diagnosed metastatic prostate cancer patients, with regular follow-up for monitoring disease progression and treatment safety. The study will be conducted at Fudan University Cancer Hospital.
Interested in participating?
Request Info18 year–80 year
Male
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Dingwei Ye, MD.
CONTACT
Dingwei Ye, MD.
CONTACT
Xiaojian Qin, MD.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ⅴ. Kidney function: serum creatinine ≤ 2×ULN or calculated creatinine clearance ≥ 30 mL/min.
Ⅵ. Coagulation function: INR ≤ 1.5.
Exclusion criteria
Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor
Participants will receive Standard Medical Therapy, which includes ADT, typically with an LHRH agonist or antagonist, to reduce testosterone levels, a key driver of prostate cancer progression. In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide. These medications block androgen receptor signaling and further inhibit the cancer's ability to grow.
Time frame: 2 years
Defined as the time from the start of treatment to radiographic evidence of disease progression, assessed by imaging techniques such as PSMA PET-CT, MRI, or CT scans, following RECIST 1.1 criteria. The primary objective is to evaluate how long patients remain free from disease progression after receiving the combination of TURP and standard systemic therapy.
Time frame: 2 years
Urinary symptom relief will be assessed using the International Prostate Symptom Score (IPSS) and objective measures like urine flow rate. The goal is to evaluate the extent to which TURP alleviates urinary obstruction and related symptoms in patients with metastatic prostate cancer.
Time frame: 2 years
Defined as the time from the start of treatment until death from any cause. For patients who are still alive, the time will be censored at the last follow-up. This secondary outcome measure aims to assess the overall survival rate of patients receiving the combination of TURP and standard systemic therapy for metastatic prostate cancer, comparing survival outcomes over the course of the study.
Time frame: 2 years
Defined as the time from the start of treatment to biochemical progression, according to the criteria set by the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA). Biochemical progression is typically defined as an increase in PSA (Prostate-Specific Antigen) level by 2 ng/mL or more above the nadir (lowest point). This measure will assess how long patients maintain PSA control after receiving the combination of TURP and standard systemic therapy.
Time frame: 3 and 6 months
The proportion of patients whose Prostate-Specific Antigen (PSA) levels decrease by more than 50% from baseline will be measured at 3 months and 6 months post-treatment. The PSA response rate will be assessed at both time points to evaluate the effectiveness of the combined TURP and standard systemic therapy in reducing PSA levels, which is a key marker of prostate cancer activity.
Time frame: Baseline, 3, 6, 12, and 24 months
This outcome will evaluate changes in patients' quality of life using the EORTC QLQ-C30 questionnaire. It assesses physical, emotional, and social well-being during and after treatment. The score ranges from 0 to 100, with higher scores indicating a better quality of life.
Contact information is provided by the study sponsor or research team.
Dingwei Ye, MD.
CONTACT
Xiaojian Qin, MD.
CONTACT
Fudan University
Other
An Open-Label, Prospective, Single-Arm Clinical, Phase II Study on the Efficacy and Safety of TURP Combined with Standard Systemic Therapy in Patients with Metastatic Prostate Cancer
Acronym: CTUSMEP01
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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