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Cystoprostatectomy Versus Radiotherapy Combined With ADT for the Treatment of cT4 Prostate Cancer With Bladder Invasion

NCT03482089 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-21

No results posted yet for this study

Summary

Prostate cancer is the most common male cancer in global, which accounts for 19% of the total and poses great hazards to male health. Unfavorable factors including prostatic specific antigen (PSA) \>20 ng/ml, Gleason score \>8, and T3/4 are significantly associated with biological recurrence, metastatic progression and poor survival in prostate cancer. In clinical T4(cT4) prostate cancer with bladder invasion patients, symptoms of hematuria, urinary urgency, bladder outlet and ureteral obstruction, and pelvic pain led to a poor quality of life.

Radical prostatectomy is crucial for the multimodal treatment of prostate cancer, but limited proof demonstrated enough advantages of the surgery in T4 tumor with bladder invasion. Radical prostatectomy could hardly meet both demands of local tumor control and urinary function. Treatment trends suggest that patients with T4 prostate cancer be treated with radiotherapy combined with androgen deprivation therapy (ADT). However, surgery enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Cystoprostatectomy offers an option of surgical treatment for T4 prostate cancer with bladder invasion，which can well remove the bladder and urethra, decrease the risk of positive surgical margins and avoid urination complications.

There is no consensus regarding optimal treatment of T4 prostate cancer and no evidence of oncological outcomes of cystoprostatectomy from clinical trials. A randomized clinical trial comparing two multimodal treatment regimens of cystoprostatectomy and radiotherapy for T4 prostate cancer with bladder invasion is therefore warranted.

Conditions

Interventions

PROCEDURE

Cystoprostatectomy

Patients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection

RADIATION

external beam radiotherapy

Patients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Hubei Cancer Hospital

    collaborator OTHER

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Zhiqiang Chen, M.D.,Ph.D · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2023-06-12
Completion
2023-06-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482089 on ClinicalTrials.gov