Safety and Efficacy of Two-step Radical Prostatectomy

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

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?

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Two-step Radical Prostatectomy

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Two-step Radical Prostatectomy	Procedure: Two-step Radical Prostatectomy; The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	Defined as the time duration from the incision at the opening to the end of closing the incision	Intraoperative
Estimated blood loss	Defined as all the blood loss counting during the surgery	Intraoperative
Hospital stay	Defined as the time duration between the first day after surgery to the day of discharge	From date of surgery until the date of discharge, an average of 7 days
Continence	Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence	2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
Lower urinary tract symptoms	Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe	1 months, 3 months, 6 months, 12 months after surgery
Erectile function	Evaluated with International Index of Erectile Function-5 (IIEF-5).The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction	6 months, 12 months and 24 months after surgery
Positive surgical margin rate	Defined as the proportion of patients with positive surgical margin of the whole prostate and the margin between the hyperplastic adenoma and the residual gland evaluated by pathologists. The location of positive margin will be documented.	Through study completion, an average of 5 year
Complication	All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system.	Through study completion, an average of 5 year
Overall survival	Number of participants who are alive after a specified duration of time	From date of randomization until the date of date of death from any cause, assessed up to 60 months
Cancer-specific survival	Number of participants who are not dead due to prostate cancer after a specified duration of time	From date of randomization until the date of date of death from cancer, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): February 15, 2033
• Study Completion (ANTICIPATED): February 15, 2033

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2022-FXY-296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No