Trial Outcomes & Findings for Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT03649841)

Last Updated: 2023-10-26

Results Overview

Percent change in peripheral blood effector T-cells will be calculated by measuring the difference of the percent peripheral blood effector T-cells for each patient between two time points: pre-treatment and post-treatment (3 months after start of ADT, which is also 1 month post-radiation in the radiation arm). Unpaired two-sample t-test or Wilcoxon rank-sum test, depending on distribution of the percent change, will be used to test the null hypothesis that the percent change in peripheral blood effector T-cells is equal between the two arms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 3 months after start of antiandrogen therapy (ADT)

Results posted on

2023-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (ADT, Abiraterone, Prednisone) Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC	Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC Radiation Therapy: Undergo neutron radiation therapy
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (ADT, Abiraterone, Prednisone) n=6 Participants Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC	Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) n=4 Participants Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC Radiation Therapy: Undergo neutron radiation therapy	Total n=10 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 6.1 • n=5 Participants	64.3 years STANDARD_DEVIATION 12 • n=7 Participants	63.0 years STANDARD_DEVIATION 8.4 • 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months after start of antiandrogen therapy (ADT)

Population: Clinical trial closed early due to poor accrual. Enrolled patient numbers are much lower than expected (10 out of 30 patients enrolled). There is no funding to run the assays to analyze the data since the trial failed to complete accrual. The original collaborators who were supposed to pay for the assays withdrew due to low patient numbers, and lack of ability to draw scientific conclusions from low patient numbers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 months after start of abiraterone acetate

The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined.

Outcome measures

Outcome measures
Measure	Arm I (ADT, Abiraterone, Prednisone) n=6 Participants Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC	Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) n=4 Participants Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC Radiation Therapy: Undergo neutron radiation therapy
Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 6 months

Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with grade 3 or higher toxicities per CTCAE v4.0, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm.

Outcome measures

Outcome measures
Measure	Arm I (ADT, Abiraterone, Prednisone) n=6 Participants Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC	Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) n=4 Participants Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC Radiation Therapy: Undergo neutron radiation therapy
Incidence of Adverse Events	2 Participants	0 Participants

Adverse Events

Arm I (ADT, Abiraterone, Prednisone)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (ADT, Abiraterone, Prednisone) n=6 participants at risk Patients receive ADT per standard of care. Beginning 2 months after start of ADT, patients also receive abiraterone acetate and prednisone per standard of care for at least 6 months in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC	Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) n=4 participants at risk Patients receive ADT, abiraterone acetate, and prednisone as in Arm I. Beginning 8-10 weeks after starting ADT and within 1 week of starting abiraterone acetate, patients also undergo 3-5 fractions of neutron radiation therapy for 2 weeks in the absence of disease progression or unacceptable toxicity. Antiandrogen Therapy: Undergo ADT Abiraterone Acetate: Undergo Abiraterone Acetate Treatment SOC Prednisone: Undergo Prednisone Treatment SOC Radiation Therapy: Undergo neutron radiation therapy
Hepatobiliary disorders ALT elevation	16.7% 1/6 • Number of events 1 • Start of Abiraterone to 6 months after start of Abiraterone. Total duration 6 months. Patients are seen in clinic every 4 weeks during the 6 months period above, and adverse events are scored per CTCAE v4.0 per physician reported outcomes.	0.00% 0/4 • Start of Abiraterone to 6 months after start of Abiraterone. Total duration 6 months. Patients are seen in clinic every 4 weeks during the 6 months period above, and adverse events are scored per CTCAE v4.0 per physician reported outcomes.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Start of Abiraterone to 6 months after start of Abiraterone. Total duration 6 months. Patients are seen in clinic every 4 weeks during the 6 months period above, and adverse events are scored per CTCAE v4.0 per physician reported outcomes.	0.00% 0/4 • Start of Abiraterone to 6 months after start of Abiraterone. Total duration 6 months. Patients are seen in clinic every 4 weeks during the 6 months period above, and adverse events are scored per CTCAE v4.0 per physician reported outcomes.

Additional Information

Dr. Jing Zeng

University of Washington

Phone: 2065984110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place