Trial Outcomes & Findings for Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy (NCT NCT00937768)

Last Updated: 2019-12-27

Results Overview

Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

2 years

Results posted on

2019-12-27

Participant Flow

Sixteen (16) participants were recruited at Mayo Clinic (Rochester) between July 2009 and June 2012.

This trial was terminated early due to funding issues.

Participant milestones

Participant milestones
Measure	Androgen Deprivation Therapy Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy Patients undergo observation every 3 months for 9 months.
Overall Study STARTED	8	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Androgen Deprivation Therapy Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy Patients undergo observation every 3 months for 9 months.
Overall Study Refused Further Treatment	3	2
Overall Study Disease Progression	1	1
Overall Study Alternate Treatment	0	1
Overall Study No Further Funding	4	4

Baseline Characteristics

Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Androgen Deprivation Therapy n=8 Participants Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=8 Participants Patients undergo observation every 3 months for 9 months.	Total n=16 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 8.6 • n=5 Participants	62.8 years STANDARD_DEVIATION 7.4 • n=7 Participants	62.0 years STANDARD_DEVIATION 7.8 • 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	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: No participants reached the 2 years follow up due to the early termination of the trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely due to funding issues. Planned analysis for Overall Survival and Prostate Cancer Specific Survival was not performed due to the nature of the closure. Thus, the number of deaths are reported below.

The number of deaths due to any cause are reported below.

Outcome measures

Outcome measures
Measure	Androgen Deprivation Therapy n=8 Participants Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=8 Participants Patients undergo observation every 3 months for 9 months.
Number of Deaths	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3

Outcome measures

Outcome measures
Measure	Androgen Deprivation Therapy n=8 Participants Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=8 Participants Patients undergo observation every 3 months for 9 months.
Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution	100 percentage of patients	37.5 percentage of patients

SECONDARY outcome

Timeframe: Baseline and months 3 and 6

Population: Patients who completed the FACT-P and had FACT-P Total Score data at each of the time points are included in each analysis at each time point below.

The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.

Outcome measures

Outcome measures
Measure	Androgen Deprivation Therapy n=7 Participants Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=7 Participants Patients undergo observation every 3 months for 9 months.
Average Overall FACT-P Total Score at Baseline, Months 3 and 6 Baseline	122.7 score on a scale Standard Deviation 5.9	114.8 score on a scale Standard Deviation 16.92
Average Overall FACT-P Total Score at Baseline, Months 3 and 6 Month 3	118.6 score on a scale Standard Deviation 19.11	117.8 score on a scale Standard Deviation 18.67
Average Overall FACT-P Total Score at Baseline, Months 3 and 6 Month 6	109.4 score on a scale Standard Deviation 23.83	136.8 score on a scale Standard Deviation 3.43

SECONDARY outcome

Timeframe: Baseline to Months 3 and 6

Population: Patients who completed the LASA and had LASA Overall Quality of Life data at each of the time points are included in each analysis at each time point below.

LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.

Outcome measures

Outcome measures
Measure	Androgen Deprivation Therapy n=7 Participants Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=7 Participants Patients undergo observation every 3 months for 9 months.
Average LASA Overall Quality of Life at Baseline, Months 3 and 6 Month 3	1.0 score on a scale Standard Deviation 1.63	7.0 score on a scale Standard Deviation 1.22
Average LASA Overall Quality of Life at Baseline, Months 3 and 6 Baseline	8.8 score on a scale Standard Deviation 0.75	6.9 score on a scale Standard Deviation 1.77
Average LASA Overall Quality of Life at Baseline, Months 3 and 6 Month 6	6.2 score on a scale Standard Deviation 3.19	8.7 score on a scale Standard Deviation 0.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.

Outcome measures

Outcome data not reported

Adverse Events

Androgen Deprivation Therapy

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

No Androgen Deprivation Therapy

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Androgen Deprivation Therapy n=8 participants at risk Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=8 participants at risk Patients undergo observation every 3 months for 9 months.
Renal and urinary disorders Urinary retention	0.00% 0/8	12.5% 1/8 • Number of events 1

Other adverse events

Other adverse events
Measure	Androgen Deprivation Therapy n=8 participants at risk Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.	No Androgen Deprivation Therapy n=8 participants at risk Patients undergo observation every 3 months for 9 months.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1	12.5% 1/8 • Number of events 2
General disorders Fatigue	62.5% 5/8 • Number of events 12	37.5% 3/8 • Number of events 3
Musculoskeletal and connective tissue disorders Bone pain	62.5% 5/8 • Number of events 17	12.5% 1/8 • Number of events 7
Musculoskeletal and connective tissue disorders Myalgia	62.5% 5/8 • Number of events 9	25.0% 2/8 • Number of events 2
Nervous system disorders Dizziness	25.0% 2/8 • Number of events 3	12.5% 1/8 • Number of events 1
Nervous system disorders Taste alteration	25.0% 2/8 • Number of events 3	12.5% 1/8 • Number of events 1
Psychiatric disorders Libido decreased	100.0% 8/8 • Number of events 26	37.5% 3/8 • Number of events 3
Renal and urinary disorders Urinary frequency	87.5% 7/8 • Number of events 15	62.5% 5/8 • Number of events 6
Renal and urinary disorders Urinary retention	87.5% 7/8 • Number of events 13	62.5% 5/8 • Number of events 16
Reproductive system and breast disorders Erectile dysfunction	100.0% 8/8 • Number of events 31	75.0% 6/8 • Number of events 15
Reproductive system and breast disorders Gynecomastia	25.0% 2/8 • Number of events 4	0.00% 0/8
Respiratory, thoracic and mediastinal disorders Dyspnea	37.5% 3/8 • Number of events 6	0.00% 0/8
Skin and subcutaneous tissue disorders Rash acneiform	37.5% 3/8 • Number of events 10	12.5% 1/8 • Number of events 1
Skin and subcutaneous tissue disorders Sweating	50.0% 4/8 • Number of events 9	25.0% 2/8 • Number of events 2
Vascular disorders Flushing	37.5% 3/8 • Number of events 4	0.00% 0/8
Vascular disorders Hot flashes	87.5% 7/8 • Number of events 21	12.5% 1/8 • Number of events 1

Additional Information

Dr. R. Jeffrey Karnes

Mayo Clinic

Phone: 507 284-4430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place