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NCT Number: NCT05722392

Safety and Efficacy of Two-step Radical Prostatectomy

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?

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two-step Radical Prostatectomy

Procedure

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

Primary outcomes

  1. Biochemical Recurrence-free Survival

    Time frame: 5 years

    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.

Secondary outcomes

  1. Surgical time

    Time frame: Intraoperative

    Defined as the time duration from the incision at the opening to the end of closing the incision

  2. Estimated blood loss

    Time frame: Intraoperative

    Defined as all the blood loss counting during the surgery

  3. Hospital stay

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

    Defined as the time duration between the first day after surgery to the day of discharge

  4. Continence

    Time frame: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery

    Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence

  5. Lower urinary tract symptoms

    Time frame: 1 months, 3 months, 6 months, 12 months after surgery

    Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe

  6. Erectile function

    Time frame: 6 months, 12 months and 24 months after surgery

    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

  7. Positive surgical margin rate

    Time frame: Through study completion, an average of 5 year

    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.

  8. Complication

    Time frame: Through study completion, an average of 5 year

    All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system.

  9. Overall survival

    Time frame: From date of randomization until the date of date of death from any cause, assessed up to 60 months

    Number of participants who are alive after a specified duration of time

  10. Cancer-specific survival

    Time frame: From date of randomization until the date of date of death from cancer, assessed up to 60 months

    Number of participants who are not dead due to prostate cancer after a specified duration of time

Study contacts

Contact information is provided by the study sponsor or research team.

Yonghong Li, M.D.

CONTACT

[email protected]

020-87343656

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Feb 10, 2023
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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