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

NCT ID: NCT03649841

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2023-02-01

Brief Summary

This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy work in treating patients with prostate cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking the production and interfering with the action of hormones. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, 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. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone with or without neutron radiation therapy may work better in treating patients with prostate cancer.

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

After completion of study treatment, patients are followed up every 4 weeks for 6 months.

Conditions

Castration-Sensitive Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Small Cell Neuroendocrine Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antiandrogen Therapy

Intervention Type: DRUG

Undergo ADT

Abiraterone Acetate

Intervention Type: DRUG

Undergo Abiraterone Acetate Treatment SOC

Prednisone

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Antiandrogen Therapy

Intervention Type: DRUG

Undergo ADT

Abiraterone Acetate

Intervention Type: DRUG

Undergo Abiraterone Acetate Treatment SOC

Prednisone

Intervention Type: DRUG

Undergo Prednisone Treatment SOC

Radiation Therapy

Intervention Type: RADIATION

Undergo neutron radiation therapy

Interventions

Antiandrogen Therapy

Undergo ADT

Intervention Type: DRUG

Abiraterone Acetate

Undergo Abiraterone Acetate Treatment SOC

Intervention Type: DRUG

Prednisone

Undergo Prednisone Treatment SOC

Intervention Type: DRUG

Radiation Therapy

Undergo neutron radiation therapy

Intervention Type: RADIATION

Other Intervention Names

ADT; Androgen Deprivation Therapy; Androgen Deprivation Therapy (ADT); Anti-androgen Therapy; Anti-androgen Treatment; Antiandrogen Treatment; Hormone Deprivation Therapy; Hormone-Deprivation Therapy; 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate; 154229-18-2; Yonsa; Zytiga; 10023; Delta 1-Cortisone; Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; NOS; Radiotherapeutics; radiotherapy; RT; ENERGY TYPE

Eligibility Criteria

Inclusion Criteria

• Pathologically proven (either histologic or cytologic) diagnosis of prostate adenocarcinoma with < 50% neuroendocrine differentiation or small cell histology.
• At least one site of nodal or distant metastatic disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or a bony metastasis that is evaluable on both computed tomography (CT) and bone scan.
• No prior orchiectomy.
• No androgen deprivation therapy such as treatment with antiandrogens, luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least one year prior to trial enrollment, and testosterone must be inside normal range prior to trial enrollment if there is prior history of ADT.
• No other systemic anti-cancer therapy for at least 1-year prior to enrollment.
• Prior prostate-directed therapies such as prostatectomy or cryotherapy are allowed.
• Prior radiation treatments are allowed (prostate or metastatic sites) but must have been completed at least 3 months prior to starting ADT for this trial.
• White blood cell (WBC) > 3000/mm^3.
• Absolute neutrophil count (ANC) > 1000/mm^3.
• Platelets > 100,000/mm^3.
• Creatinine < 1.5 institutional upper limit of normal (ULN) or calculated creatinine clearance > 30 ml/min.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 3 x institutional ULN (unless patient has documented Gilbert's syndrome).
• No steroids for at least 2 weeks prior to enrollment, and patient must not be expected to require steroids during the study period, other than the typical low dose steroid that is given with abiraterone (typically prednisone or prednisolone at 5 mg twice daily).
• Zubrod performance status 0-2.
• Patient must sign study specific informed consent prior to study entry.
• Men who are sexually active must use medically acceptable forms of contraception.

Exclusion Criteria

• Other illnesses with a life expectancy of less than 6 months, including but not limited to unstable angina, symptomatic congestive heart failure, cardiac arrhythmias.
• Psychological or social issues that would prevent patients from informed consent or complying with study requirements.
• Subject has a history of unexplained loss of consciousness or transient ischemic attack within 12 months of treatment start.
• Individuals on active treatment for a different cancer are excluded. Individuals with a history of other malignancies are eligible if they are deemed by the investigator to be at low risk for recurrence of that malignancy.
• Known brain metastasis.
• Known allergies, hypersensitivity, or intolerance to abiraterone or prednisone.
• Prior ADT less than a year, or greater than two months, prior to trial enrollment or prior ADT with testosterone less than normal.
• There is a potential drug interaction when abiraterone is concomitantly used with a CYP2D6 substrate narrow therapeutic index (e.g., thioridazine, dextromethorphan), or strong CYP3A4 inhibitors (e.g., atazanavir, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) or strong inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine). Caution should be used when patients are on one of these drugs.
• Patients with a history of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis, human immunodeficiency virus (HIV), or chronic liver disease are not eligible.
• Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jing Zeng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Zeng

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2018-01548

Identifier Type: REGISTRY

Identifier Source: secondary_id

9938

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA097186

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1001784

Identifier Type: -

Identifier Source: org_study_id