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

NCT01023061 | Completed Phase 2 Results DMC

• 4 other identifiers: 7048NCI-2009-013467048 - AbiRADP30CA015704
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adenocarcinoma of the Prostate; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Up to 24 months after initiation of radiation therapy

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

  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.

  Week 12

Secondary Outcomes (1)

• Median Time to Prostate Specific Antigen Progression

  6 months

Study Arms (1)

Treatment (antihormone therapy and radiation therapy)

EXPERIMENTAL

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.

Drug: abiraterone acetate; Drug: prednisone; Drug: leuprolide acetate; Other: laboratory biomarker analysis; Radiation: external beam radiation therapy; Drug: goserelin acetate

Interventions

abiraterone acetate DRUG

Given PO

Also known as: Zytiga

Treatment (antihormone therapy and radiation therapy)

prednisone DRUG

Given PO

Also known as: DeCortin, Deltra

Treatment (antihormone therapy and radiation therapy)

leuprolide acetate DRUG

Given via injection

Also known as: Enantone, Lupron, Lupron Depot

Treatment (antihormone therapy and radiation therapy)

laboratory biomarker analysis OTHER

Correlative study

Treatment (antihormone therapy and radiation therapy)

external beam radiation therapy RADIATION

Undergo radiotherapy

Treatment (antihormone therapy and radiation therapy)

goserelin acetate DRUG

Given via injection

Also known as: Zoladex

Treatment (antihormone therapy and radiation therapy)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MultiCare Regional Cancer Center - Tacoma

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Cho E, Mostaghel EA, Russell KJ, Liao JJ, Konodi MA, Kurland BF, Marck BT, Matsumoto AM, Dalkin BL, Montgomery RB. External beam radiation therapy and abiraterone in men with localized prostate cancer: safety and effect on tissue androgens. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):236-43. doi: 10.1016/j.ijrobp.2015.01.020. Epub 2015 Mar 12.

  PMID: 25772183 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone; Leuprolide; Goserelin

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)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Bruce Montgomery
• Organization: University of Washington

rbmontgo@uw.edu

206-598-0860

Study Officials

• Robert Montgomery

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: March 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Locations

US (2)