Trial Outcomes & Findings for Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer (NCT NCT01342367)

Last Updated: 2025-06-10

Results Overview

Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

74 participants

Primary outcome timeframe

Baseline, 6 months, and 24 months

Results posted on

2025-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	SOC Cohort the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks	Oral ADT Group Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
Overall Study STARTED	32	42
Overall Study COMPLETED	30	40
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SOC Cohort the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks	Oral ADT Group Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOC Cohort n=30 Participants the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks	Oral ADT Group n=40 Participants Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks	Total n=70 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	40 Participants n=7 Participants	70 Participants n=5 Participants
Age, Continuous	72 years STANDARD_DEVIATION 1 • n=5 Participants	72 years STANDARD_DEVIATION 1 • n=7 Participants	72 years STANDARD_DEVIATION 1 • 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	40 Participants n=7 Participants	70 Participants n=5 Participants
Race/Ethnicity, Customized African American	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	40 Participants n=7 Participants	70 Participants n=5 Participants
Prostate-Specific Antigen (PSA)	17.9 ng/mL n=5 Participants	12.6 ng/mL n=7 Participants	15.3 ng/mL n=5 Participants
Adult Comorbidity Evaluation >=2	18 Participants n=5 Participants	30 Participants n=7 Participants	48 Participants n=5 Participants
Adult Comorbidity Evaluation <2	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months, and 24 months

Outcome measures

Outcome measures
Measure	SOC Cohort n=30 Participants the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks	Oral ADT Group n=40 Participants Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire Baseline	92 score on a scale Standard Deviation 0.04	89 score on a scale Standard Deviation 0.04
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire 6 month	81 score on a scale Standard Deviation 0.07	88 score on a scale Standard Deviation 0.07
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire 24 month	83 score on a scale Standard Deviation 0.05	84 score on a scale Standard Deviation 0.05

SECONDARY outcome

Timeframe: 4 years

Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value.

Outcome measures

Outcome measures
Measure	SOC Cohort n=30 Participants the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks	Oral ADT Group n=40 Participants Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks
Percentage of Participants Free From Biochemical Failure	81 percentage of participants	88 percentage of participants

Adverse Events

SOC Cohort

Serious events: 2 serious events

Other events: 14 other events

Deaths: 8 deaths

Oral ADT Group

Serious events: 2 serious events

Other events: 18 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	SOC Cohort n=30 participants at risk the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks	Oral ADT Group n=40 participants at risk Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks
Gastrointestinal disorders GI Toxicity	6.7% 2/30 • Number of events 2 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.	5.0% 2/40 • Number of events 2 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.

Other adverse events

Other adverse events
Measure	SOC Cohort n=30 participants at risk the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks	Oral ADT Group n=40 participants at risk Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks
Gastrointestinal disorders GI Toxicity	33.3% 10/30 • Number of events 10 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.	30.0% 12/40 • Number of events 12 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.
Renal and urinary disorders GU toxicity	46.7% 14/30 • Number of events 14 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.	45.0% 18/40 • Number of events 18 • from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.

Additional Information

Dr. Stanley Liauw

The University of Chicago

Phone: 7737026870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place