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Trial record 70 of 1439 for:    prostate cancer AND radiation

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

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ClinicalTrials.gov Identifier: NCT03649841
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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.

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Adenocarcinoma Prostate Carcinoma Metastatic in the Bone Prostate Small Cell Carcinoma Drug: Antiandrogen Therapy Drug: Abiraterone Acetate Drug: Prednisone Radiation: Radiation Therapy Drug: Abiraterone Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : November 16, 2022


Arm Intervention/treatment
Active Comparator: 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.
Drug: Antiandrogen Therapy
Undergo ADT
Other Name: ADT

Drug: Abiraterone Acetate
Undergo Abiraterone Acetate Treatment SOC
Other Names:
  • 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate
  • 154229-18-2

Drug: Prednisone
Undergo Prednisone Treatment SOC
Other Names:
  • 10023
  • Delta 1-Cortisone

Drug: Abiraterone
Undergo Abiraterone
Other Names:
  • 154229-19-3
  • 17-(3-Pyridyl)androsta-5
  • CB 7598

Experimental: 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.
Drug: Antiandrogen Therapy
Undergo ADT
Other Name: ADT

Drug: Abiraterone Acetate
Undergo Abiraterone Acetate Treatment SOC
Other Names:
  • 17-(3-Pyridyl)-5,16-androstadien-3beta-acetate
  • 154229-18-2

Drug: Prednisone
Undergo Prednisone Treatment SOC
Other Names:
  • 10023
  • Delta 1-Cortisone

Radiation: Radiation Therapy
Undergo neutron radiation therapy
Other Name: Cancer Radiotherapy

Drug: Abiraterone
Undergo Abiraterone
Other Names:
  • 154229-19-3
  • 17-(3-Pyridyl)androsta-5
  • CB 7598




Primary Outcome Measures :
  1. Percent change in peripheral blood effector T-cells (CCR7-/CD45RO) [ Time Frame: Baseline to 3 months after start of antiandrogen therapy (ADT) ]
    Percent change in peripheral blood effector T-cells will be calculated by measuring the difference of the percent peripheral blood effector T-cells for each patient between two time points: pre-treatment and post-treatment (3 months after start of ADT, which is also 1 month post-radiation in the radiation arm). Unpaired two-sample t-test or Wilcoxon rank-sum test, depending on distribution of the percent change, will be used to test the null hypothesis that the percent change in peripheral blood effector T-cells is equal between the two arms.


Secondary Outcome Measures :
  1. Rate of undetectable PSA (< 0.2) [ Time Frame: At 6 months after start of abiraterone acetate ]
    The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined.

  2. Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 6 months ]
    Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with such toxicities, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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 seizure or any condition that may predispose to seizure including, but not limited to, underlying brain injury, stroke in the past 6 months, primary brain tumors, brain metastases, prior seizures.
  • 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 prior to trial enrollment or prior ADT with testosterone less than normal.
  • Must not have a gastrointestinal condition that would interfere with absorption.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649841


Contacts
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Contact: Jing Zeng 206-598-4100 jzeng13@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Jing Zeng    206-598-4100    jzeng13@uw.edu   
Principal Investigator: Jing Zeng         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jing Zeng University of Washington

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03649841     History of Changes
Other Study ID Numbers: RG1001784
NCI-2018-01548 ( Registry Identifier: NCI )
9938 ( Other Identifier: FHCRC )
P30CA015704 ( U.S. NIH Grant/Contract )
P50CA097186 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Washington:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carcinoma
Adenocarcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Genital Diseases, Male
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Prednisone
Abiraterone Acetate
Androgen Antagonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents