Trial Outcomes & Findings for Evaluate Recovery of Testosterone for Patients Using Eligard (NCT NCT01136226)

Results Overview

To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

6 mos

Results posted on

2018-10-24

Participant Flow

Patients were enrolled from 2003-2008 at a medical office setting

Participant milestones

Participant milestones
Measure	Single Arm- Eligard Eligard 22.5mg is only intervention administered
Overall Study STARTED	42
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate Recovery of Testosterone for Patients Using Eligard

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm- Eligard n=42 Participants Eligard 22.5mg is only intervention administered
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	70.8 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 mos

To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Outcome measures

Outcome measures
Measure	Single Arm- Eligard n=29 Participants Eligard 22.5mg is only intervention administered
Serum Testosterone Recovery	6 Months Interval 1.0 to 18.0

SECONDARY outcome

Timeframe: 6 months

Population: data were not collected

Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Single Arm- Eligard

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

Heather Thomas, Administrator

Chesapeake Urology Research Associates

Phone: 443.471.5742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place