NCT05722392Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jan 2023
- Start date
- 15 Feb 2023
- Primary completion date
- 15 Feb 2033
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT05722392
What you commit to
- Study type: Observational
- Planned participants: 30
- From 15 Feb 2023 to the primary completion date, 15 Feb 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
- Any contraindication of surgery or anaesthesia
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.