Evaluating the safety and effectiveness of a two-step surgery for prostate cancer
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
This study is testing a two-step surgery for men with low- to intermediate-risk prostate cancer and an enlarged prostate to see if it makes the procedure easier and improves cancer control.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Sex | Male |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05722392 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of a two-step radical prostatectomy for patients with low- to intermediate-risk prostate cancer who also have an enlarged prostate and severe benign prostatic hyperplasia. The study will investigate whether this surgical approach can reduce the difficulty of the procedure and provide promising oncologic control. Patients will be evaluated based on specific criteria, including prostate volume and Gleason score, to determine their eligibility for the intervention.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with localized prostate cancer, having a prostate volume greater than 70mL and a Gleason score of 7 or lower.
Not a fit: Patients who have undergone previous therapies for prostate cancer or have contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer surgical option for patients with complex prostate conditions.
How similar studies have performed: While this specific approach is novel, similar surgical interventions have shown promise in improving outcomes for prostate cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yonghong Li, M.D.
- Email: liyongh@sysucc.org.cn
- Phone: 020-87343656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.