Comparing two robotic surgery methods for prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multicenter, randomized controlled trial that aims to compare the effectiveness of single-port extraperitoneal robotic-assisted radical prostatectomy (RARP) versus multi-port transperitoneal RARP in treating localized prostate cancer. A total of 480 patients will be enrolled and randomly assigned to one of the two surgical approaches, with a focus on measuring functional recovery rates and other important outcomes. The study will monitor patients for one year post-surgery to gather comprehensive perioperative data and assess recovery metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men aged 18 years ≤ age ≤ 75 years;
2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.
3. Gleason Score\<8.
4. PSA\<20ng/ml.
5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;
6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery;
7. Physiological condition acceptable for laparoscopic surgery;
8. Willing to cooperate and complete the study follow-up and related examinations;
9. The subject or his agent voluntarily participates in this trial and signs the written informed consent;
10. The questionnaire can be completed in Chinese.
11. The patient has been informed of the trial;

Exclusion Criteria:

1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \> 20ng/ml);
2. Special type of prostate cancer， such as neuroendocrine etc.;
3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;
4. Recent surgery of rectum, perianal abscess or around fistula and perineal area;
5. Patients who have undergone previous electro-prostatectomy/enucleation of the prostate;
6. Non-recurrent patients with less than 12 months of follow-up;
7. ECOG\>1.
8. Combination of other systemic tumors;
9. had received any type of preoperative antitumor therapy;
10. Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;
11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;
12. Other conditions that the researchers believe may affect the experimental results or are unethical;

Where it's running

• Changzheng hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shancheng Ren, MD/PhD
• Email: renshancheng@gmail.com
• Phone: 021-81886999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

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  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Two-fraction radiotherapy for localized prostate cancer

  This study is testing if giving radiotherapy in just two sessions instead of five can effectively treat localized prostate cancer while causing fewer side effects for patients.

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• Effects of exercise therapy on prostate cancer indicators

  This study is testing if a home-based walking program can help men with low-risk prostate cancer show better signs of their condition compared to those who stick to their usual exercise routines.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California and 9 other locations · NCT05751434

• High dose rate brachytherapy for localized prostate cancer

  This study is testing a new way to give high dose rate brachytherapy to treat localized prostate cancer in two sessions to see if it's safe for patients with low to intermediate risk.

  Recruiting University of California, San Francisco · San Francisco, California · NCT05665738

• Exercise after pelvic radiation to see if it lowers colorectal cancer risk

  This study tests whether regular walking therapy after pelvic radiation for prostate cancer can influence markers of colorectal cancer in colon tissue and blood.

  Recruiting at 2 sites City of Hope Medical Center · Duarte, California and 1 other locations · NCT07790718

• MRI-based microboost SBRT with de-escalated whole-gland radiation for localized prostate cancer

  This study tests whether giving a focused 45 Gy microboost to MRI-defined lesions with smaller whole-gland doses (30 or 35 Gy) is safe and effective for men with low- to intermediate-risk localized prostate cancer.

  Recruiting Phase 2 Georgetown University · Washington D.C., District of Columbia · NCT07644598

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.