Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00776594
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen Deprivation Therapy — DRUG
    leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
  • bicalutamide — DRUG
    50mg orally daily for 6 months
  • bevacizumab — DRUG
    15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Study Details

The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).

Key Dates

First listed
Oct 21, 2008
Start date
Oct 31, 2008
Status verified
Sep 2016
Primary completion
Dec 31, 2014
Completion
Sep 30, 2016

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Androgen Deprivation Therapy Plus Bevacizumab
  • Experimental: Group 2
    Androgen Deprivation Therapy Alone

Primary Outcome Measure

Relapse-free Survival [ Time Frame: 2 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205-
Beth-Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Karmanos Cancer InstituteDetroitMichigan48201-
Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
The University of Texas M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-5669-

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins University· Baltimore, MDBeth-Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAKarmanos Cancer Institute· Detroit, MICancer Institute of New Jersey· New Brunswick, NJMemorial Sloan-Kettering Cancer Center· New York, NY

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