Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Two-step Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Two-step Radical Prostatectomy
- description
- Two-step Radical Prostatectomy
- interventionNames
- Procedure: Two-step Radical Prostatectomy
Primary outcomes (1)
- measure
- Biochemical Recurrence-free Survival
- timeFrame
- 5 years
- description
- 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 (10)
- measure
- Surgical time
- timeFrame
- Intraoperative
- description
- Defined as the time duration from the incision at the opening to the end of closing the incision
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available