Trial Outcomes & Findings for External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer (NCT NCT00388804)

Results Overview

Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

3 months up to 2 years

Results posted on

2012-08-08

Participant Flow

Recruitment period: 02/16/2005 to 09/08/2010. All recruitment was at UT MD Anderson Cancer Center.

Of the 39 enrolled participants, one participant was excluded from the trial before assignment to groups.

Participant milestones

Participant milestones
Measure	RT Group 1 Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.	RT Group 2 + Hormone Therapy Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
Overall Study STARTED	17	21
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RT Group 1 n=17 Participants Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.	RT Group 2 + Hormone Therapy n=21 Participants Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)	Total n=38 Participants Total of all reporting groups
Age Continuous	66.3 years n=5 Participants	64.5 years n=7 Participants	65.3 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	21 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months up to 2 years

Population: One person was not treated and therefore excluded from the analysis.

Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.

Outcome measures

Outcome measures
Measure	RT Group 1 n=17 Participants Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.	RT Group 2 + Hormone Therapy n=21 Participants Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
Prostate Specific Antigen (PSA) Failures	0 participants	0 participants

Adverse Events

RT Group 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

RT Group 2 + Hormone Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RT Group 1 n=17 participants at risk Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.	RT Group 2 + Hormone Therapy n=21 participants at risk Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
Renal and urinary disorders Urinary frequency	11.8% 2/17 • 4 years and 9 months	4.8% 1/21 • 4 years and 9 months
Renal and urinary disorders Urinary incontinence	5.9% 1/17 • 4 years and 9 months	0.00% 0/21 • 4 years and 9 months
Renal and urinary disorders Dysuria	5.9% 1/17 • 4 years and 9 months	0.00% 0/21 • 4 years and 9 months
Gastrointestinal disorders Diarrhea	5.9% 1/17 • 4 years and 9 months	0.00% 0/21 • 4 years and 9 months
Metabolism and nutrition disorders Alanine transaminase (ALT)	5.9% 1/17 • 4 years and 9 months	0.00% 0/21 • 4 years and 9 months
Metabolism and nutrition disorders Aspartate transaminase (AST)	5.9% 1/17 • 4 years and 9 months	0.00% 0/21 • 4 years and 9 months

Additional Information

Andrew Lee, MD / Professor

UT MD Anderson Cancer

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place