Safety and Efficacy of Two-step Radical Prostatectomy

Launched by SUN YAT-SEN UNIVERSITY · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a surgery called two-step radical prostatectomy for men with low- to intermediate-risk prostate cancer, particularly those who also have an enlarged prostate. The main goals are to see if this two-step surgery is safe and if it effectively controls the cancer. Researchers want to understand if this approach can make the surgery easier for patients and if it will successfully manage the cancer.

To be eligible for this trial, participants must be diagnosed with localized prostate cancer through a biopsy and imaging tests, have a prostate volume larger than 70 mL, a specific cancer score (Gleason score of 7 or lower), and a prostate-specific antigen (PSA) level below 20 ng/mL. They should also expect to live for at least another 10 years. Participants will need to give their consent to join the study. It’s important to note that individuals who have previously undergone other prostate treatments or have conditions that prevent surgery will not be eligible. If you participate, you will be closely monitored throughout the study to ensure your safety and track the effectiveness of the treatment.

Gender

MALE

Eligibility 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