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Adjuvant Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0M0 Prostate Cancer
This study is currently recruiting participants.
Verified by Norris Comprehensive Cancer Center, September 2008
Sponsors and Collaborators: Norris Comprehensive Cancer Center
U.S. Army Medical Research and Materiel Command
Information provided by: Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00669162
  Purpose

Following a radical prostatectomy and lymph node sampling, eligible patients will undergo adjuvant radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Radiation: conformal radiation therapy
Drug: Casodex , Zoladex, Lupron
Phase I
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Docetaxel Goserelin Leuprolide acetate Leuprolide Bicalutamide Liothyronine sodium Triiodothyronine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Trial of Adjuvant 3-D Conformal Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0M0 Prostate Cancer

Further study details as provided by Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine whether greater than 95% of patients who undergo adjuvant hormonal therapy, radiation therapy and docetaxel after a radical prostatectomy can safely tolerate and complete this regimen. [ Time Frame: Approximately 6-8 mos. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Docetaxel
    20mg/M2 IV weekly for 7 weeks
    Radiation: conformal radiation therapy
    66.0 Gy delivered in 33 daily fractions
    Drug: Casodex , Zoladex, Lupron
    Casodex (50 mg po daily) & Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)
Detailed Description:

To determine the safety and feasibility of combining weekly docetaxel with adjuvant 3-D conformal radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0M0 prostate cancer after a radical prostatectomy.

To obtain preliminary information regarding the efficacy of combining weekly docetaxel with adjuvant 3-D conformal radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0M0 prostate cancer by determining PSA failure free survival.

To assess the expression of molecular markers, such as Ki-67, bcl-2, bax, bcl-xL, bcl-2/bax ratio, apoptotic index, PAR1, chromogranin A, serotonin, and synaptophysin in the radical prostatectomy specimens and to explore the possible association with PSA failure free survival.

To assess baseline and longitudinal changes in health-related quality of life outcomes during and after therapy (at 3, 6, 12 and 24 months

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented adenocarcinoma of the prostate.
  • Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with at least 1 of 3 disease criteria which must be met as indicated below:

    • a) Pathologic T2N0M0 disease with positive margins and gleason score greater than or equal to 8
    • b) Pathologic T3aN0M0 disease with extracapsular extension and Gleason Score greater than equal to 8
    • c) Pathologic T3bN0M0 disease
  • Undetectable PSA level less than or equal to 0.2 within 8 weeks after radical prostatectomy
  • No prior chemotherapy, pelvic irradiation, or androgen ablation
  • Karnofsky Performance Status greater than equal to 70
  • Hematologic parameters must be within the following limits:
  • WBC greater than equal to 3,000
  • Platelet Count greater than equal to 130,000
  • Hemoglobin level greater than equal to 11.0
  • Creatinine less than equal to 2.5
  • Normal liver function defined as the following: Total bilirubin below the upper limit of normal AND AST, ALT, and Alkaline Phosphatase must be within a defined range of eligibility.
  • Patients with a history of an invasive malignancy within the last 5 years are not eligible for the protocol; patients who are NED from a prior invasive malignancy for at least 5 years or longer are eligible for the trial. Patients with history of benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas are eligible as long as the benign tumor is under local control regardless of the time frame. Patients with concurrent adequately treated basal cell or squamous cell carcinoma of the skin are also eligible for the protocol.
  • Patients must be informed of the investigative nature of the treatment, must give appropriate informed consent to protocol procedures and must sign an Informed Consent Documentation Form.
  • Must not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and follow-up.
  • Age greater than or equal to 18 years
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter, which should be for at least 6 months after the completion of protocol therapy

Exclusion Criteria:

  • Patients who have received prior chemotherapy, pelvic irradiation or androgen ablation including neoadjuvant hormonal therapy prior to radical prostatectomy.
  • Any coexisting medical condition precluding full compliance with the study.
  • Patients with active infections or known infection with HIV.
  • Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.
  • Known contraindication to dexamethasone
  • Patients with a history of a hypersensitivity reaction to products containing Polysorbate 80
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669162

Contacts
Contact: Linda Bailey-Theders, RN 323-865-3071 Bailey-Theders_L@ccnt.usc.edu

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Sherida Padilla     323-865-0454     Padilla_S@ccnt.usc.edu    
Principal Investigator: Parvesh Kumar, MD            
Sponsors and Collaborators
Norris Comprehensive Cancer Center
U.S. Army Medical Research and Materiel Command
  More Information

Responsible Party: University of Southern California ( Parvesh Kumar. MD )
Study ID Numbers: 4P-06-3
Study First Received: April 24, 2008
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00669162  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Goserelin
Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009