Trial Outcomes & Findings for Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT01731912)

NCT ID: NCT01731912

Last Updated: 2019-01-18

Results Overview

Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: At week 24
• Results posted on: 2019-01-18

Participant Flow

16 started therapy. 14 completed therapy

Participant milestones

Measure	Degarelix Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Degarelix Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Overall Study noncompliance	2

Baseline Characteristics

Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Degarelix n=16 Participants Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Age, Continuous	65 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 24

Population: Tissue DHT at 24 weeks

Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.

Outcome measures

Measure	Degarelix n=14 Participants Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry	0.6 pg/mg Standard Deviation 0.34

PRIMARY outcome

Timeframe: At week 24

Population: Tissue testosterone levels at 24 weeks

Outcome measures

Measure	Degarelix n=14 Participants Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry	0.17 pg/mg Standard Deviation 0.13

Adverse Events

Degarelix

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. Bruce Montgomery

University of Washington

Phone: 206-598-0860

Email: rbmontgo@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place