Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone

NCT06060587 | Withdrawn Phase 2 DMC FDA Drug

• 4 other identifiers: NU 23U08NCI-2023-07135STU00220128P30CA060553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, randomized, open label study comparing first line therapy with AThis is a phase II, randomized, open label study comparing first line therapy with ADT + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC). This is a phase II, randomized, open label study comparing first line therapy with Androgen Deprivation Therapy (ADT) + abiraterone (doublet arm) or ADT + abiraterone + docetaxel (triplet arm) in low volume, metastatic hormone sensitive prostate cancer (mHSPC). The hypothesis being asked in this trial is whether first line treatment with ADT plus an androgen receptor pathway inhibitor (abiraterone) as a doublet regimen compared to ADT plus an androgen receptor pathway inhibitor (abiraterone) and docetaxel, as a triplet regimen results in superior outcomes for patients with low volume mHSPC. We plan to enroll patients with mHPSC that meet the CHAARTED criteria for low disease volume. Patients will be randomized 1:1 to either treatment arm:

• doublet arm: abiraterone +ADT or
• triplet arm: abiraterone + ADT + docetaxel. All subjects must receive ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy, started = 12 weeks before randomization.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Assess Progression Free Survival (PFS)

  Calculated the progression-free survival time as the time that elapses between the date of randomization and the day of first documented disease progression (per RECIST 1.1 or PCWG3) or death from any cause for all evaluable patients. PFS will be calculated based on the Kaplan-Meier estimates of PFS for each treatment arm (abiraterone+docetaxel+ADT compared to abiraterone+ADT).

  Up to 1 year after completion of study treatment

Secondary Outcomes (4)

• Assess Overall Survival (OS)

  Up to 1 year after completion of study treatment

• Assess PSA Response Rate

  6 months (+/- 30 days) after randomization

• Assessment of Time to castration resistant prostate cancer

  Up to 1 year after completion of study treatment

• Assess time to compare for any difference in efficacy between arms

  Up to 1 year after completion of study treatment

Other Outcomes (2)

• Assess Quality of Life (QoL)

  Time between the initiation of trial therapy to 30 days from the last dose of study drug

• Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs)

  Time between the initiation of trial therapy to 30 days from the last dose of study drug

Study Arms (2)

Triplet Arm

EXPERIMENTAL

Abiraterone+Docetaxel+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT.

Drug: Docetaxel; Drug: ADT; Drug: Abiraterone

Doublet Arm

ACTIVE COMPARATOR

Abiraterone+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Treatment of abiraterone should start ≤14 days after patient randomization. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.

Drug: ADT; Drug: Abiraterone

Interventions

Docetaxel DRUG

75 mg/m2 via IV

Triplet Arm

ADT DRUG

Prior to randomization as part of standard of care.

Doublet Arm; Triplet Arm

Abiraterone DRUG

1000 mg by mouth

Doublet Arm; Triplet Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed PCa and imaging evidence of metastatic disease on CT, MRI, and/or bone scan. A PSMA PET scan may be used, but findings confirming metastatic disease (ex. A lymph node \> 1 cm or a bone lesion) must be observed on the CT portion of the scan.
• Patients must have low volume metastatic disease per the CHAARTED \[1, 2\] criteria; Low volume is defined as metastasis in lymph nodes outside of the pelvis and/or boney lesions (\< 4 boney lesions, none outside of the axial skeleton). No visceral metastasis allowed. Metastatic disease must be documented either by a positive bone scan, contrast-enhanced abdominal/pelvic/chest computed tomography (CT) scan, magnetic resonance imaging scan or a prostate-specific membrane antigen (PSMA) PET scan. If a PSMA PET scan is used, the CT portion must confirm lymph node enlargement \> 1cm or evidence of sclerosis for boney lesions. Metastatic disease is defined as either malignant lesions in the bone and/or measurable lymph nodes above the aortic bifurcation. Only patients with non-regional lymph node metastases (M1a) and/or bone metastases (M1B) will be eligible.
• Patients must have measurable disease as determined per RECIST version 1.1 See protocol for the evaluation of measurable disease. Lymph nodes are measurable if the short axis diameter is ≥ 10mm.
• Patient must be candidates for ADT, docetaxel and abiraterone therapy per treating investigator's judgment.
• Patients may have started ADT (LHRH agonist/antagonist or orchiectomy) for ≤ 12 weeks before randomization, with or without first generation anti-androgen.
• Patients must exhibit a/an ECOG performance status of ≤ 1.
• Patients must have adequate organ and bone marrow function as defined in the protocol.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• If a patient has known brain metastases, they must have received radiation per SOC to control disease to be eligible for this trial.
• The effects of abiraterone and docetaxel on the developing human fetus are unknown. For this reason and because chemotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic: patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) nor donate sperm, from time of informed consent, for the duration of study participation, and for 3 months following completion of abiraterone and 6 months following completion of docetaxel therapy. Should a patient's partner become pregnant or suspect they are pregnant while patient's partner is participating in this study, patient's partner should inform their treating physician immediately.
• Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior treatment with:
• Second generation ARPIs such as enzalutamide, ARN-509, abiraterone, other investigational AR inhibitors
• Cytochrome P17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer.
• Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
• Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
• Known hypersensitivity to any of the study drugs, study drug classes or excipients in the formation of any of the study drugs
• Contraindication to both CT and MRI contrast agent
• Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure
• Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
• Patients who are unable to swallow oral medication, have malabsorption syndrome, have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, small bowel resection) or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the oral bioavailability of any of the study drugs
• Patients with history of or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with history of or evidence of chronic hepatitis C virus (HCV) infection, must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable antiviral regimen and have a CD4 count ≥ 200/mcL.
• Patients with chronic liver disease with a need for treatment
• Prior systemic treatment with an azole drug (e.g., fluconazole, itraconazole) within 4 weeks of randomization,

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sarah Fenton, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: October 19, 2023
• Primary Completion: May 3, 2024
• Study Completion (Estimated): December 22, 2030
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)