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

• Sponsor: University of Utah (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03827473
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Castration-Sensitive Prostate Carcinoma; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer; Stage IVA Prostate Cancer; Stage IVB Prostate Cancer	Drug: Abiraterone Acetate; Drug: Antiandrogen Therapy; Drug: Docetaxel; Drug: Prednisone; Other: Quality-of-Life Assessment; Other: Questionnaire Administration	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality of life between screening and month 12 of the study.

SECONDARY OBJECTIVES:

1. To assess prostate specific androgen (PSA) response rates across the entire population and compared between groups.

2. To assess impact of abiraterone and docetaxel on additional quality of life measurements and quality of life trends throughout the duration of the study.

3. To assess the potential clinical efficacy between treatment groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer
• Actual Study Start Date: Feb 8, 2019
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Antiandrogen Therapy; Given per standard of care; Other Names: ADT Androgen Deprivation Therapy Anti-androgen Therapy Anti-androgen Treatment Antiandrogen Treatment Hormone Deprivation Therapy Hormone-Deprivation Therapy ; Drug: Docetaxel; Given IV; Other Names: Docecad RP56976 Taxotere Taxotere Injection Concentrate ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Other: Questionnaire Administration; Ancillary studies
Experimental: Arm B (ADT, abiraterone acetate, prednisone) 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.	Drug: Abiraterone Acetate; Given PO; Other Names: CB7630 Zytiga ; Drug: Antiandrogen Therapy; Given per standard of care; Other Names: ADT Androgen Deprivation Therapy Anti-androgen Therapy Anti-androgen Treatment Antiandrogen Treatment Hormone Deprivation Therapy Hormone-Deprivation Therapy ; Drug: Prednisone; Given PO; Other Names: .delta.1-Cortisone 1, 2-Dehydrocortisone Adasone Cortancyl Dacortin DeCortin Decortisyl Decorton Delta 1-Cortisone Delta-Dome Deltacortene Deltacortisone Deltadehydrocortisone Deltasone Deltison Deltra Econosone Lisacort Meprosona-F Metacortandracin Meticorten Ofisolona Orasone Panafcort Panasol-S Paracort PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Predniment Prednisonum Prednitone Promifen Servisone SK-Prednisone ; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment ; Other: Questionnaire Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Life - FACT-P [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.

Secondary Outcome Measures

1. Prostate-specific Antigen (PSA) Response [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.

2. Change in Quality of Life - FACT/GOG-NTX [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.

3. Change in Quality of Life - PROMIS Fatigue [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.

4. Prostate Specific Antigen Progression Free Survival (PSA-PFS) [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 on the study was only followed for 3 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically diagnosed adenocarcinoma of the prostate.

• Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT, prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2.

• Absolute neutrophil count (ANC) >= 1.5 k/uL.

• Platelets >= 100 k/uL.

• Hemoglobin >= 9 g/dL.

• Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= 1.5 x ULN.

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 4 x ULN for subjects with liver metastases.

• Creatinine < 1.5 x ULN OR

• Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 x ULN by Cockcroft-Gault formula or standard institutional practice.

• Highly effective method of contraception for both male and female partners of subjects throughout the study and for at least 3 months after last study treatment administration if the risk of conception exists.

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

• Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as defined by the treating physician.

Exclusion Criteria:

• No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy (example: bicalutamide) is allowed.

• Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).

• Patients have a histologic diagnosis of small cell prostate cancer or pure squamous cell prostate cancer.

• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.

• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

• Cardiovascular disorders:

• Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias within 3 months of study enrollment.

• Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.

• Stroke (including transient ischemic attack (TIA)), myocardial infarction (MI), or other ischemic event, or arterial thromboembolic event within 3 months before first dose.

• Other clinically significant disorders that would preclude safe study participation. As defined by the treating physician.

• Known history of testing positive for human immunodeficiency virus (HIV) and cluster of differentiation 4 (CD4) count is below 200 or known acquired immunodeficiency syndrome diagnosis.

• Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if anti-HCV antibody screening test positive) and a detectable viral count at screening.

• Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use while on trial for the duration of potential docetaxel treatment. Live vaccine use is acceptable after chemotherapy or for patients randomized to the abiraterone arm. There are no restrictions on inactive viruses.

• Known prior severe hypersensitivity to investigational product or any component in its formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Benjamin Maughan, MD, Huntsman Cancer Institute/ University of Utah

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2019

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT03827473
• Other Study ID Numbers: HCI115099
• First Posted: Feb 1, 2019
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Hypersensitivity; Ascorbic Acid; Prednisone; Cortisone; Docetaxel; Abiraterone Acetate; Methyltestosterone; Hormones; Estrogens, Conjugated (USP); Androgens; Androgen Antagonists

Study Results

Participant Flow

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	1	0
COMPLETED	0	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Ethnicity (NIH/OMB) () []
Hispanic or Latino
Not Hispanic or Latino
Unknown or Not Reported
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Life - FACT-P
Description	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.
Time Frame	Planned for up to one year, but actual was 3 months

Outcome Measure Data

Analysis Population Description

There were no participants on Arm B to analyze.

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Measure Participants	1	0
Baseline Score	139.83
Month 3 Score	127

2. Secondary Outcome

Title	Prostate-specific Antigen (PSA) Response
Description	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.
Time Frame	Planned for up to 18 months, but actual was 3 months

Outcome Measure Data

Analysis Population Description

There were no participants on Arm B to analyze.

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Measure Participants	1	0
Count of Participants [Participants]	1 Infinity

3. Secondary Outcome

Title	Change in Quality of Life - FACT/GOG-NTX
Description	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.
Time Frame	Planned for up to 18 months, but actual was 3 months

Outcome Measure Data

Analysis Population Description

There were no participants on Arm B to analyze.

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Measure Participants	1	0
Baseline Score	131.83
Month 3 Score	126

4. Secondary Outcome

Title	Change in Quality of Life - PROMIS Fatigue
Description	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.
Time Frame	Planned for up to 18 months, but actual was 3 months

Outcome Measure Data

Analysis Population Description

There were no participants on Arm B to analyze.

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Measure Participants	1	0
Baseline Score	10
Month 3 Score	16

5. Secondary Outcome

Title	Prostate Specific Antigen Progression Free Survival (PSA-PFS)
Description	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.
Time Frame	Planned up to 18 months, but actual was 3 months

Outcome Measure Data

Analysis Population Description

There were no participants on Arm B to be analyzed.

Arm/Group Title	Arm A (ADT, Docetaxel)	Arm B (ADT, Abiraterone)
Arm/Group Description	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.	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.
Measure Participants	1	0
Count of Participants [Participants]	1 Infinity

Adverse Events

Time Frame	Planned for up to 18 months, but due to low enrollment and early participant discontinuation, the actual time frame was 3 months.
Adverse Event Reporting Description	Information about adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, lab test or other means, were abstracted from clinic notes and recorded in the participant's study chart. The safety profile for the drugs involved in this study have been characterized extensively in previous clinical trials and standard clinical contexts. As such, safety data collection for this study was limited to ≥ Grade 3 adverse events.
Arm/Group Title	Arm A (ADT, Docetaxel)		Arm B (ADT, Abiraterone)
Arm/Group Description	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.		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.
All Cause Mortality
	Arm A (ADT, Docetaxel)		Arm B (ADT, Abiraterone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	Arm A (ADT, Docetaxel)		Arm B (ADT, Abiraterone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm A (ADT, Docetaxel)		Arm B (ADT, Abiraterone)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.