Localized Prostate Carcinoma, Prostate Adenocarcinoma
Conditions
Keywords
Prostate Cancer, Robotic-assisted Radical Prostatectomy, da Vinci surgical robot, Potency, Non-inferiority, RCT, Continence
Brief summary
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Detailed description
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
Interventions
PROCEDURESingle-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
PROCEDUREMulti-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Sponsors
Shanghai Changzheng Hospital
Shanghai Zhongshan Hospital
ShuGuang Hospital
Eastern Hepatobiliary Surgery Hospital
The First Affiliated Hospital of Guangzhou Medical University
Sir Run Run Shaw Hospital
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Potency recovery rate | 3 months after surgery | Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continence recovery rate | Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively | The rate of recovery of continence postoperatively, measured in the number of pads used per day. |
| PSA | Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively | PSA status postoperatively，measured in ng/mL |
| Potency recovery rate | Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively | Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score（from 0-25 score, a higher score means a worse outcome）, and phosphodiesterase5 (PDE-5）inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome）. |
| Clavien-Dindo complication score | Every day during period of hospitalization (up to 7 days) | Clavien-Dindo complication score measured in the following grades（a higher grade means a worse outcome） ： First grade：complications that do not require medication, surgery or endoscopic treatment. Second grade： complications require to be treated with drugs, including blood transfusion and parenteral nutrition. Third grade： complications that require surgery, endoscopy, or radiation therapy. Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury. Fifth grade: death. |
| Operative time | During operation（on an average of 90-120minutes ） | Time elapsed from skin incision to placement of the final skin suture, measured in minutes |
| Estimated blood loss | During operation（on an average of 90-120minutes ） | Estimated blood loss, measured in volume (mL) |
| Number of additional ports | During operation（on an average of 90-120minutes ） | Number of additional ports needed in surgery |
| Period of hospitalization | During period of hospitalization (up to 7 days) | Hospital stay, counted in days from the first day of hospitalization to discharge |
| Period of hospitalization post surgery | Post surgery, during period of hospitalization (up to 7 days) | Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge |
Countries
China
Contacts
CONTACTShancheng Ren, MD/PhD
CONTACTYi fan Chang
Outcome results
None listed