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

NCT03482089 | Unknown DMC

• 1 other identifier: CZQ5208
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The percentage of subjects in a study who have survived at the the endpoint of the observation since randomization or the interval between randomization and death from any cause.

  10 years

Secondary Outcomes (5)

• Biochemical progression-free survival (BPFS)

  10 years

• Cancer-specific survival (CSS)

  10 years

• Functional Assessment of Cancer Therapy-General (FACT-G) score

  10 years

• Functional Assessment of Cancer Therapy-Prostate (FACT-P) score

  10 years

• complications

  10 years

Study Arms (2)

Cystoprostatectomy

EXPERIMENTAL

(Open, laparoscopic or robot-assisted ) cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection; without adjuvant androgen deprivation therapy;

Procedure: Cystoprostatectomy

Radiotherapy

ACTIVE COMPARATOR

Radiotherapy by external beam radiotherapy (81 Gy，2.4-4 Gy per fraction over 4-6 weeks); with adjuvant androgen deprivation therapy for the least 3 years

Radiation: external beam radiotherapy

Interventions

Cystoprostatectomy PROCEDURE

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

Cystoprostatectomy

external beam radiotherapy RADIATION

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

Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≤75, at the time of randomization
• Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
• Untreated for surgery, radiotherapy, or androgen deprivation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
• A life expectation of at least 10 years
• Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
• Eligible for either treatment of cystoprostatectomy or radiotherapy
• Signed informed consent should be obtained from both the patient or one authorized legal relative.

You may not qualify if:

• Patients with a history of other cancer diagnoses except non-melanoma skin cancer
• Patients with pelvic surgery
• Patients with severe systemic diseases
• severe kidney function -glomerular filtration rate (GFR) \< 30 ml/min or elevated liver transaminases above \> 10 upper limit of normal (ULN)
• Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition

Sponsors & Collaborators

• Tongji Hospital: lead
• Chinese PLA General Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Hubei Cancer Hospital: collaborator

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Zhiqiang Chen, M.D.,Ph.D

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Zhiqiang Chen, M.D.,Ph.D

CONTACT

008613995512271; zhqchen8366@163.com

Peng Yuan, M.D.

CONTACT

008615927679790; mwyuanpeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 29, 2018
• Study Start: June 12, 2018
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

CN (1)