Trial Outcomes & Findings for Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer (NCT NCT01023061)

Last Updated: 2017-06-06

Results Overview

Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Up to 24 months after initiation of radiation therapy

Results posted on

2017-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Antihormone Therapy and Radiation Therapy) Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Antihormone Therapy and Radiation Therapy) Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Overall Study Withdrawal prior to treatment	2

Baseline Characteristics

Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Antihormone Therapy and Radiation Therapy) n=24 Participants Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Age, Continuous	61 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months after initiation of radiation therapy

Population: Treated patients

Outcome measures

Outcome measures
Measure	Treatment (Antihormone Therapy and Radiation Therapy) n=22 Participants Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given PO prednisone: Given PO leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0	6 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Treated patients with measurable tissue DHT

The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.

Outcome measures

Outcome measures
Measure	Treatment (Antihormone Therapy and Radiation Therapy) n=22 Participants Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given PO prednisone: Given PO leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry	0.050 pg/mg Interval 0.05 to 0.05

SECONDARY outcome

Timeframe: 6 months

Population: Treated patients

Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Antihormone Therapy and Radiation Therapy) n=22 Participants Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given PO prednisone: Given PO leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Median Time to Prostate Specific Antigen Progression	5 years Standard Deviation 1

Adverse Events

Treatment (Antihormone Therapy and Radiation Therapy)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Antihormone Therapy and Radiation Therapy) n=22 participants at risk Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection
Blood and lymphatic system disorders Lymphopenia	86.4% 19/22 • Number of events 19 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Cardiac disorders Hypertension	36.4% 8/22 • Number of events 8 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Metabolism and nutrition disorders ALT and AST: increased	31.8% 7/22 • Number of events 7 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
General disorders fatigue	68.2% 15/22 • Number of events 15 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Investigations hypokalemia syndrome	54.5% 12/22 • Number of events 12 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Vascular disorders Hot flashes	68.2% 15/22 • Number of events 15 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Hepatobiliary disorders Hyperbilirubinemia	22.7% 5/22 • Number of events 5 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
General disorders insomnia	13.6% 3/22 • Number of events 3 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Reproductive system and breast disorders erectile dysfunction	31.8% 7/22 • Number of events 7 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Gastrointestinal disorders Diarrhea	40.9% 9/22 • Number of events 9 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
Renal and urinary disorders urinary tract discomfort	86.4% 19/22 • Number of events 19 • Median follow-up 21 months Tracked grade 1 and 2 toxicities \>10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.

Additional Information

Bruce Montgomery

University of Washington

Phone: 206-598-0860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place