NCT03827473: ACADEMIC

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

Terminated Phase 2 Results posted Last updated 25 June 2020

What this trial tests

Phase 2 trial testing Abiraterone Acetate in Castration-Sensitive Prostate Carcinoma in 1 participant. Terminated before completion.

Timeline

8 February 2019

Primary endpoint
31 July 2019

31 July 2019

Quick facts

Lead sponsor	University of Utah
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	8 February 2019
Primary completion	31 July 2019
Estimated completion	31 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Abiraterone Acetate (ABIRATERONE) — full drug profile →
• Antiandrogen Therapy — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• Prednisone (prednisone) — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Castration-Sensitive Prostate Carcinoma — all drugs for Castration-Sensitive Prostate Carcinoma →
• Metastatic Prostatic Adenocarcinoma — all drugs for Metastatic Prostatic Adenocarcinoma →
• Stage IV Prostate Cancer — all drugs for Stage IV Prostate Cancer →
• Stage IVA Prostate Cancer — all drugs for Stage IVA Prostate Cancer →

Sponsor

University of Utah

Who can join

18 and older, male only, with Castration-Sensitive Prostate Carcinoma or Metastatic Prostatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Quality of Life - FACT-P Primary · Planned for up to one year, but actual was 3 months

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.

Baseline Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	139.83

Month 3 Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	127

Prostate-specific Antigen (PSA) Response Secondary · Planned for up to 18 months, but actual was 3 months

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.

Group	Value	95% CI
Arm A (ADT, Docetaxel)	1

Change in Quality of Life - FACT/GOG-NTX Secondary · Planned for up to 18 months, but actual was 3 months

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.

Baseline Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	131.83

Month 3 Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	126

Change in Quality of Life - PROMIS Fatigue Secondary · Planned for up to 18 months, but actual was 3 months

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.

Baseline Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	10

Month 3 Score

Group	Value	95% CI
Arm A (ADT, Docetaxel)	16

Prostate Specific Antigen Progression Free Survival (PSA-PFS) Secondary · Planned up to 18 months, but actual was 3 months

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

Group	Value	95% CI
Arm A (ADT, Docetaxel)	1

Sponsor's own description

This phase II trial studies how well docetaxel or abiraterone acetate work when combined with androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the body. It is not yet known whether docetaxel or abiraterone acetate work better when combined with ADT in treating patients with hormone sensitive prostate cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.