Trial Outcomes & Findings for Vessel Sparing Prostate Radiation Therapy (NCT NCT02958787)

Results Overview

The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: 1. Sexually active without aids 2. Sexually active with aids 3. Not sexually active with or without aids

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

135 participants

Primary outcome timeframe

5 years from end of radiation treatment

Results posted on

2018-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning
Overall Study STARTED	135
Overall Study COMPLETED	135
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vessel Sparing Prostate Radiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=135 Participants Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years from end of radiation treatment

The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: 1. Sexually active without aids 2. Sexually active with aids 3. Not sexually active with or without aids

Outcome measures

Outcome measures
Measure	Intervention n=135 Participants Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures Radiation Therapy: Radiation Therapy Using MRI Based Treatment Planning
The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids	88 percentage of patients Interval 81.0 to 92.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Spratt, MD

University of Michigan Comprehensive Cancer Center

Phone: 734-232-5244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place