Safety and Efficacy of Two-step Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Two-step Radical Prostatectomy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia
Overview
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?
Interventions
- Procedure Two-step Radical Prostatectomy
The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland
Primary outcome measures
- Biochemical Recurrence-free Survival [Time frame: 5 years]
Secondary outcome measures (10)
- Surgical time [Time frame: Intraoperative]
- Estimated blood loss [Time frame: Intraoperative]
- Hospital stay [Time frame: From date of surgery until the date of discharge, an average of 7 days]
- Continence [Time frame: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery]
- Lower urinary tract symptoms [Time frame: 1 months, 3 months, 6 months, 12 months after surgery]
- Erectile function [Time frame: 6 months, 12 months and 24 months after surgery]
- Positive surgical margin rate [Time frame: Through study completion, an average of 5 year]
- Complication [Time frame: Through study completion, an average of 5 year]
- Overall survival [Time frame: From date of randomization until the date of date of death from any cause, assessed up to 60 months]
- Cancer-specific survival [Time frame: From date of randomization until the date of date of death from cancer, assessed up to 60 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
- Any contraindication of surgery or anaesthesia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT05722392 · 2022-FXY-296