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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer

Short name RAD1

NCTNCT01023061 (opens ClinicalTrials.gov in a new tab)Other id7048Other idNCI-2009-01346Other id7048 - AbiRADOther id7048

Overview

Status
Completed
Phase
Phase 2
Enrollment
24 participants (actual)
Sponsor
University of Washington · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2010
Primary completion
Sept 2015
Completion
Sept 2015
First posted
2 Dec 2009 (estimated)
Last update posted
6 Jun 2017
Conditions
Adenocarcinoma of the Prostate · Stage II Prostate Cancer · Stage III Prostate Cancer · Stage IV Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 2

    RAD1

    NCT01023061

    Mar 2010 to Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.

Interventions

  • abiraterone acetateDrug
  • prednisoneDrug
  • leuprolide acetateDrug
  • laboratory biomarker analysisOther
  • external beam radiation therapyRadiation
  • goserelin acetateDrug

Arms1

  • Experimental

    Treatment (antihormone therapy and radiation therapy)

    Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

    Time frame · Up to 24 months after initiation of radiation therapy

    Registry description

    Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.

  2. Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry

    Time frame · Week 12

    Registry description

    The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.

Secondary outcomes(1)
  1. Median Time to Prostate Specific Antigen Progression

    Time frame · 6 months

    Registry description

    Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Up to 24 months after initiation of radiation therapy

Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

GroupValue (Participants)
Treatment (Antihormone Therapy and Radiation Therapy)6
Primary outcomeMedian· Week 12

Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry

GroupValue (pg/mg)
Treatment (Antihormone Therapy and Radiation Therapy)0.050
Secondary and other outcome results(1)
Secondary outcomeMean· 6 months

Median Time to Prostate Specific Antigen Progression

GroupValue (years)Spread
Treatment (Antihormone Therapy and Radiation Therapy)51

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment (Antihormone Therapy and Radiation Therapy)Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. abiraterone acetate: Given orally prednisone: Given orally leuprolide acetate: Given via injection laboratory biomarker analysis: Correlative study external beam radiation therapy: Undergo radiotherapy goserelin acetate: Given via injection0 / 240 / 2219 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Willing and able to provide written informed consent * Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial placement * Written Authorization for Use and Release of Health and Research Study Information has been obtained * Histologically proven adenocarcinoma of the prostate * Patients must be candidates for short or long term androgen deprivation in combination with external beam radiotherapy (RT) based on the following criteria: * Intermediate Risk Disease: T2b/c, or Gleason 7, or Prostate Specific Antigen 10-20 * High Risk Disease: Gleason 8-10, or Prostate specific antigen\> 20, or T3/4 * Patients may not have received any prior pharmacologic therapy or radiation therapy (RT) for prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Karnofsky \>= 60% * Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the Principal Investigator * White blood cell count: \>= 3,000/mm\^3 * Absolute granulocyte count: \>= 1,000/mm\^3 * Platelets: \>= 100,000/mm\^3 * Hemoglobin \>= 10g/dL * Potassium \>= 3.5 mmol/L * Serum creatinine: =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) \< 2.5 x ULN * Alanine transaminase (ALT) \< 2.5 x ULN * Total bilirubin: =\< 1.5 x ULN (except for patients with documented Gilbert's disease) Exclusion Criteria: * Patients may not be receiving any investigational agents * Concurrent enrollment in another clinical investigational drug or device study is prohibited * The concurrent administration of other anticancer therapy, including cytotoxic or hormonal agents (except Luteinizing hormone releasing hormone agonists), or immunotherapy, is prohibited during neoadjuvant concurrent and adjuvant therapy * Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible * Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible * Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible * History of pituitary or adrenal dysfunction * Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible * Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible * Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone, Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications * Patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the Principal Investigator on a case by case basis * Use of other investigational drug therapy for any reason is prohibited * Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible * Patients who have chronic active hepatitis or acute hepatitis will not be eligible * Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible * Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible * Uncontrolled hypertension within the screening period (systolic blood pressure \[BP\] \>= 160 mmHg or diastolic BP \>= 95 mmHg) * Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy * History of congestive heart failure of any severity * Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer * History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug * Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral hypoglycemics) * Patients unwilling to use contraceptives while on study

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