Trial Outcomes & Findings for Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer (NCT NCT03827473)

Results Overview

The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Planned for up to one year, but actual was 3 months

Results posted on

2020-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (ADT, Docetaxel) Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (ADT, Docetaxel) Participants receive androgen deprivation therapy (ADT) per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive androgen deprivation therapy (ADT) per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Planned for up to one year, but actual was 3 months

Population: There were no participants on Arm B to analyze.

The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead.

Outcome measures

Outcome measures
Measure	Arm A (ADT, Docetaxel) n=1 Participants Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Change in Quality of Life - FACT-P Baseline Score	139.83 score on a scale	—
Change in Quality of Life - FACT-P Month 3 Score	127 score on a scale	—

SECONDARY outcome

Timeframe: Planned for up to 18 months, but actual was 3 months

Population: There were no participants on Arm B to analyze.

PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study.

Outcome measures

Outcome measures
Measure	Arm A (ADT, Docetaxel) n=1 Participants Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Prostate-specific Antigen (PSA) Response	1 Participants	—

SECONDARY outcome

Timeframe: Planned for up to 18 months, but actual was 3 months

Population: There were no participants on Arm B to analyze.

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life.

Outcome measures

Outcome measures
Measure	Arm A (ADT, Docetaxel) n=1 Participants Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Change in Quality of Life - FACT/GOG-NTX Baseline Score	131.83 score on a scale	—
Change in Quality of Life - FACT/GOG-NTX Month 3 Score	126 score on a scale	—

SECONDARY outcome

Timeframe: Planned for up to 18 months, but actual was 3 months

Population: There were no participants on Arm B to analyze.

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue.

Outcome measures

Outcome measures
Measure	Arm A (ADT, Docetaxel) n=1 Participants Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Change in Quality of Life - PROMIS Fatigue Baseline Score	10 score on a scale	—
Change in Quality of Life - PROMIS Fatigue Month 3 Score	16 score on a scale	—

SECONDARY outcome

Timeframe: Planned up to 18 months, but actual was 3 months

Population: There were no participants on Arm B to be analyzed.

Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months.

Outcome measures

Outcome measures
Measure	Arm A (ADT, Docetaxel) n=1 Participants Participants receive ADT per standard of care and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.	Arm B (ADT, Abiraterone) Participants receive ADT per standard of care, abiraterone acetate PO daily, and prednisone PO twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Prostate Specific Antigen Progression Free Survival (PSA-PFS)	1 Participants	—

Adverse Events

Arm A (ADT, Docetaxel)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B (ADT, Abiraterone)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Data Manager

Huntsman Cancer Institute Research Compliance Office

Phone: 8015850601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place