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Therapeutic Areas: Oncology | Nephrology | Urology | Family Medicine
Disease Category: Prostate Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E3805 Phase III Randomized Study of Chemohormonal Therapy Versus Androgen-Ablation Therapy in Patients With Extensive Metastatic Prostate Cancer

Purpose

Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer.

Patient Inclusion Criteria:

  • Histologically or cytologically confirmed prostate cancer
  • High-volume metastatic disease meeting any of the following criteria:
    1. Visceral metastases (extranodal)
    2. Bone metastases
    3. At least 4 bone lesions
    4. At least 1 bone lesion must be outside of the vertebral column or pelvis
    5. On androgen-deprivation therapy for < 120 days
    6. Prostate-specific antigen (PSA) level may not have risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization

Patient Exclusion Criteria:

  • At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
  • Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:
    1. Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:
    2. PSA < 0.1 ng/dL after prostatectomy plus hormonal therapy
    3. PSA < 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
    4. Therapy lasted no more than 24 months
    5. Last depot injection must have expired by the 24-month mark
    6. Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
    7. Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
    8. No prior chemotherapy in adjuvant or neoadjuvant setting
    9. No prior hormone therapy in the metastatic setting
    10. More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
  • Patients can not simultaneously enroll on CALGB 90202
  • Concurrent participation in nontherapeutic trials allowed
  • Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy
  • No concurrent 5-alpha reductase inhibitors
  • ECOG performance status (PS) 0-2
  • PS 2 eligible only if decline in PS is due to metastatic prostate cancer
  • No prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin
  • Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
  • No peripheral neuropathy > grade 1
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No active cardiac disease, including the following:
    1. Active angina
    2. Symptomatic congestive heart failure
    3. Myocardial infarction within the past 6 months

To Learn more
Phase

3

Gender

Male

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183157

Date Last Changed: July 17, 2013


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