Trial Outcomes & Findings for Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence (NCT NCT00003645)

Last Updated: 2020-04-28

Results Overview

To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

Beginning of the study up to 5 years

Results posted on

2020-04-28

Participant Flow

The study terminated early with low accrual with insufficient data for analysis.

Participant milestones

Participant milestones
Measure	Arm A Goserelin + Bicalutamide (one year)	Arm B No initial treatment
Overall Study STARTED	30	34
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Goserelin + Bicalutamide (one year)	Arm B No initial treatment
Overall Study Death	4	1
Overall Study Lost to Follow-up	7	8
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=30 Participants Goserelin + Bicalutamide (one year)	Arm B n=34 Participants No initial treatment	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	26 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants 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	30 Participants n=5 Participants	34 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Beginning of the study up to 5 years

Population: The study terminated early without any participants reaching the 5 years on study analysis point.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

To measure the differences in quality of life between wives of participants in the androgen ablation condition compared to wives of patients in the control condition by using quality of life assessments. The following questionnaires were completed in the clinic setting and used to assess Health related (HRQoL): Medical Outcomes Study 36-Item Short Form (SF-36), University of California-Los Angeles Sexual Function Scale (UCLA-SFS), and Southwest Oncology Group Treatment-Specific Symptoms Scale (SWOG-TSSS). The SF-36 was analysed using a composite score for each of physical health and mental health. SF-36, UCLA-SFS, SWOGTSSS were combined to classify participants' quality of life.

Outcome measures

Outcome measures
Measure	Arm I - Leuprolide + Flutamide n=30 Participants Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months	Arm II - No Treatment n=34 Participants Arm II: Patients receive no initial treatment.
Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life	19 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

To determine the impact of one year of total androgen ablation on quality of life mentally, physically and sexual function. The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36-Item Short Form (SF-36) and University of California-Los Angeles Sexual Function Scale (UCLA-SFS). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Arm I - Leuprolide + Flutamide n=21 Participants Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months	Arm II - No Treatment n=22 Participants Arm II: Patients receive no initial treatment.
Quality of Life for Participants Mental	55 score on a scale Interval 51.0 to 59.0	54 score on a scale Interval 52.0 to 57.0
Quality of Life for Participants Physical	49 score on a scale Interval 44.0 to 54.0	49 score on a scale Interval 44.0 to 54.0
Quality of Life for Participants Sexual Function	5 score on a scale Interval 0.0 to 8.0	28 score on a scale Interval 15.0 to 39.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after treatment

Population: Due to poor study accrual there were not enough data collected to be analyzed to determine the markers of prognosis.

To obtain blood/tissue samples from patients at high risk for failure post prostatectomy to evaluate markers of prognosis.

Outcome measures

Outcome data not reported

Adverse Events

Arm I - Leuprolide + Flutamide

Serious events: 6 serious events

Other events: 25 other events

Deaths: 4 deaths

Arm II - No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm I - Leuprolide + Flutamide n=30 participants at risk Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months	Arm II - No Treatment Arm II: Patients receive no initial treatment.
Skin and subcutaneous tissue disorders Urticaria	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Infections and infestations Infection	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Blood and lymphatic system disorders DVT	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Cardiac disorders Chest Pain	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Renal and urinary disorders Urinary Infection	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Gastrointestinal disorders Inguinal Hernia	3.3% 1/30 • Number of events 1 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A

Other adverse events

Other adverse events
Measure	Arm I - Leuprolide + Flutamide n=30 participants at risk Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months	Arm II - No Treatment Arm II: Patients receive no initial treatment.
General disorders Fatigue	56.7% 17/30 • Number of events 17 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Vascular disorders Hot Flashes	83.3% 25/30 • Number of events 25 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Gastrointestinal disorders Diarrhea	23.3% 7/30 • Number of events 7 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Reproductive system and breast disorders Gynecomastia	30.0% 9/30 • Number of events 9 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Psychiatric disorders Decreased Libido	26.7% 8/30 • Number of events 8 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Skin and subcutaneous tissue disorders Skin Rash	16.7% 5/30 • Number of events 5 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Investigations Weight Gain	13.3% 4/30 • Number of events 4 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A
Psychiatric disorders Insomnia	13.3% 4/30 • Number of events 4 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A	— 0/0 • 1 Year (duration of study treatment) AEs and SAEs were only assessed and documented for participants on treatment arm A

Additional Information

Dr. Curtis A. Pettaway, M.D.- Professor, Urology

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place