Safety and Efficacy of Two-step Radical Prostatectomy

NCT05722392 | Recruiting

• 1 other identifier: 2022-FXY-296
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical Recurrence-free Survival

  Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater.

  5 years

Secondary Outcomes (10)

• Surgical time

  Intraoperative

• Estimated blood loss

  Intraoperative

• Hospital stay

  From date of surgery until the date of discharge, an average of 7 days

• Continence

  2 weeks, 1 months, 3 months, 6 months, 12 months after surgery

• Lower urinary tract symptoms

  1 months, 3 months, 6 months, 12 months after surgery

Study Arms (1)

Two-step Radical Prostatectomy

Two-step Radical Prostatectomy

Procedure: Two-step Radical Prostatectomy

Interventions

Two-step Radical Prostatectomy PROCEDURE

The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland

Two-step Radical Prostatectomy

Eligibility Criteria

• Gender Eligibility Details: Male with prostate cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia

You may qualify if:

• Diagnosed as prostate cancer pathologically by prostate biopsy
• Evaluated as localized prostate cancer by imaging studies
• Prostate volume\>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
• Gleason score≤ 4+3=7
• Preoperative PSA\<20ng/mL
• Estimated survival\> 10 years；
• Informed consent is obtained from the patient

You may not qualify if:

• The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
• Any contraindication of surgery or anaesthesia

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, 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

Central Study Contacts

Yonghong Li, M.D.

CONTACT

020-87343656; liyongh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 10, 2023
• Study Start: February 15, 2023
• Primary Completion (Estimated): February 15, 2033
• Study Completion (Estimated): February 15, 2033
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)