APPRO: a trial comparing conventional open operation for prostate cancer with robot-assisted, 'minimally invasive' operatio

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN06393679
• Lead Sponsor: Sahlgrenska University Hospital (Sweden)

Brief Summary

2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21114378 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24025241 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23906418 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27531014 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31068176 results (added 10/05/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32343155 results (added 29/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33743059/ (added 22/03/2021) 2024 Results article in https://doi.org/10.1186/s12885-024-12236-3 (added 12/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-07
• Study Completion: 2011-11-07
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4003

Inclusion Criteria

Current information as of 02/09/2009:
1. Men with localised prostate cancer, stage T1-T3
2. No signs of distant metastases, i.e. stage M0
3. Prostate-Specific Antigen (PSA) <=20
4. All Gleason gradings
5. The patient should in all other aspects be judged suitable for radical prostatectomy
6. The patient must accept the potential complications with the operation
7. Age <=75 years
8. No other cancer in case history

Added 03/11/2009:
The accrual of patients includes every patient at each participating hospital, who gives informed consent, regardless of the experience of the surgeon. Thus the trial will also include patients operated by a surgeon in training (an experience of less than 100 cases). The total number of patients included will therefore surpass the numbers needed for the primary outcome variable.

Initial information at time of registration:
1. Men with localised prostate cancer, stage T1-T2
2. No signs of distant metastases, i.e. stage M0
3. Prostate-Specific Antigen (PSA) <=20
4. All Gleason gradings
5. The patient should in all other aspects be judged suitable for radical prostatectomy
6. The patient must accept the potential complications with the operation
7. Age <=75 years
8. No other cancer in case history

For the randomised substudy on regional lymph node dissection:
1. Gleason score >=7
2. PSA <15

Exclusion Criteria

Current information as of 02/09/2009:
History of earlier/other cancer (does not include basal cell cancer)

Initial information at time of registration:
1. Body Mass Index (BMI) >35
2. History of earlier/other cancer (does not include basal cell cancer)
3. Men with prostate cancer stage =T3
4. Distant metastases
5. PSA >20
6. Patient not suitable for laparoscopic operation
7. Age >75 years
8. Concerning the randomised study of regional lymph node dissection:
8.1. Gleason <7 och/eller
8.2. PSA =15

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erectile dysfunction and urinary leakage within 24 months of radical prostatectomy. The evaluation of these symptoms will be through detailed self evaluation questionnaires, specifically constructed and validated for this population. The questionnaires will be answered before and 3, 12 and 24 months after the operation. Similar techniques have been used before in a large Swedish randomised trial comparing open radical prostatectomy to 'watchful waiting' in early prostate cancer. <br><br>Added 11/05/2010:<br>Urinary leakage as registered 12 months postoperatively. <br><br>Added 04/01/2011:<br>The definition of urinary incontinence used for the interim analysis was incontinence = change of pad/equivalent once daily or more. This definition will be used for the analysis of the primary end-point incontinence 12 months postoperatively.