Trial Outcomes & Findings for Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer (NCT NCT00223665)

Results Overview

Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years.

Results posted on

2018-08-07

Participant Flow

The target population for this trial was men with localized prostate cancer who had a rising PSA after definitive therapy (radiation therapy, brachytherapy, or radical prostatectomy). Patients were enrolled from Jan 1997 through Sept 2006 at the University of Washington and the Seattle Cancer Care Alliance.

Participant milestones

Participant milestones
Measure	Intermittent Androgen Suppression (IAS) Intermittent Androgen Suppression in 9 month cycles: 1. Flutamide, 250 mg by mouth 3 times daily for a total of two weeks 2. Leuprolide Acetate, 7.5mg intramuscular injections every 4 weeks for a total of nine months
Overall Study STARTED	102
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intermittent Androgen Suppression (IAS) n=102 Participants Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of first treatment until the date of development of CR, metastatic progression, or study withdrawal, whichever came first, assessed up to 16 years.

Population: 62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient PSA measurements to assess androgen independence.

Monthly Prostate-Specific Antigen (PSA) testing to assess the point at which each patient's disease stops responding to Androgen Deprivation Therapy (ADT). Androgen Independence (AI), also know as Castrate Resistance (CR), was defined as 2 serial rises in PSA while on ADT with Testosterone levels \<50 ng/dL.

Outcome measures

Outcome measures
Measure	Intermittent Androgen Suppression (IAS) n=62 Participants Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
Time to Androgen Independence of Serum Prostate-Specific Antigen (PSA)	4.0 years Interval 0.5 to 8.6

PRIMARY outcome

Timeframe: From date of first treatment until the date of death or study withdrawal, whichever came first, assessed up to 16 years.

Population: 62 subjects were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), having a measurable treatment break afterwards, and having sufficient data to assess survival status.

Assessment of overall survival measured as median time from completion of first full cycle of IAS until date of death from any cause.

Outcome measures

Outcome measures
Measure	Intermittent Androgen Suppression (IAS) n=62 Participants Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
Effect of IAS on Overall Survival.	6.6 years Interval 2.9 to 13.0

SECONDARY outcome

Timeframe: From screening prior to first dose of ADT through the start of the second cycle of ADT.

Population: 56 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.

Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point.

Outcome measures

Outcome measures
Measure	Intermittent Androgen Suppression (IAS) n=56 Participants Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS Post Cycle 1 versus Baseline	-3.4 Percent change in BMD
Change in Standardized Bone Mineral Density (BMD) of the Spine During IAS Pre Cycle 2 versus Post Cycle 1	1.4 Percent change in BMD

SECONDARY outcome

Timeframe: From screening prior to first dose of ADT through the start of the second cycle of ADT.

Population: Out of 102 enrolled subjects, 56 were evaluable for this outcome measure, defined as having completed first cycle of ADT (9 months), no prior or concurrent use of bisphosphonates, and a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2.

Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health. Percent change was assess for each patient at each time point.

Outcome measures

Outcome measures
Measure	Intermittent Androgen Suppression (IAS) n=56 Participants Intermittent Androgen Suppression in 9 month cycles with a combination of a two-week lead-in of Flutamide, followed by 9 monthly injections of Leuprolide Acetate.
Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS Pre Cycle 2 versus Post Cycle 1	-0.2 Percent change of BMD
Change in Standardized Bone Mineral Density (BMD) of the Left Hip During IAS Post Cycle 1 versus Baseline	-1.2 Percent change of BMD

SECONDARY outcome

Timeframe: From screening prior to first dose of ADT through the start of the second cycle of ADT.

Population: 38 subjects were evaluable for this outcome measure, defined as meeting all of the following: having completed first cycle of ADT (9 months); no prior or concurrent use of bisphosphonates; a minimum of 3 DEXA scans: prior to cycle 1, after cycle 1, and prior to cycle 2; having baseline DEXA BMD within normal range at both spine and left hip.

Dual-energy x-ray absorptiometry (DEXA) scans were performed prior to first cycle of ADT, after completion of the first cycle of ADT, and prior to the start of the second cycle of ADT. Bone Mineral Density (BMD) was a assessed in g/cm\^2 as a indicator of bone health for each patient at each time point. This measure was defined as the percentage of participants with normal BMD scores at baseline who developed Osteopenia after the first cycle of ADT.