NCT01717677

Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Association of Urologic Oncology (AUO) · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

Detailed description

The study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences. The Following hypotheses will be tested: * Radiation is not relevantly worse compared to prostatectomy with regard to time to prostate cancer-related deaths * Permanent seed implantation therapy not inferior to prostatectomy with regard to time to prostate cancer-related deaths. * Active Surveillance does not lead to a significant decrease of time to prostate cancer-related deaths compared to prostatectomy. That for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. Randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	radical prostatectomy
RADIATION	percutaneous radiation therapy
RADIATION	permanent seed implantation
PROCEDURE	Active Surveillance

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-01-31
• Completion: 2018-04-30
• First posted: 2012-10-30
• Last updated: 2021-02-10

Locations

2 sites across 1 country: Germany