Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3N0 Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00669162
First received: April 24, 2008
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative 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: Radiation Therapy
Drug: Casodex and Zoladex (or Lupron)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • To determine whether greater than or equal to 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: 25
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT, Docetaxel, Hormonal Therapy
Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)
Drug: Docetaxel
20mg/m2 IV weekly for 7 weeks
Other Name: Taxotere
Radiation: Radiation Therapy
66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx
Drug: Casodex and Zoladex (or Lupron)
Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)
Other Names:
  • Bicalutaminde
  • Leuprolide

Detailed Description:

To determine the safety and feasibility of combining post-operative radiation therapy, and hormonal therapy (6 months) and concurrent docetaxel in men with high risk pathologic T2-3N0 prostate cancer after a radical prostatectomy.

To obtain preliminary information regarding the efficacy of combining weekly docetaxel with adjuvant radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0 prostate cancer by determining 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:

  • Only those patients with adenocarcinoma of the prostate who have undergone a radical prostatectomy with pelvic lymph node sampling and found to have high risk non-metastatic disease with undetectable, persistent or decreasing post-operative PSA levels, or who have subsequently experienced a rise in PSA, will be eligible for the trial as described below in the inclusion and exclusion 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 the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:

    • a) "Adjuvant High Risk Group" (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:

      1. Pathologic T2N0 disease with positive margins and Gleason score ≥8, or
      2. Pathologic T3aN0disease with extracapsular extension and Gleason Score ≥ 8, or
      3. Pathologic T3bN0disease with any Gleason Score
    • b) "Salvage High Risk Group" are those patients with PSA biochemical failure defined by 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:

      1. Pathologic T3bN0 disease with any Gleason score, or
      2. Pathologic T2-3aN0 disease with Gleason score ≥ 8,
      3. Pathologic T2-3aN0 disease with PSA doubling time ≤10 months, or
      4. Pathologic T2-3aN0 disease with Pre-radiation therapy PSA level ≥1.0 ng/ml
  • Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
  • No prior chemotherapy, or pelvic irradiation
  • Karnofsky Performance Status ≥70
  • Hematologic parameters must be within the following limits:

    • WBC ≥ 3,000
    • Platelet Count ≥ 130,000/ mm3
    • Hemoglobin level ≥ 11.0 g/dl
    • Creatinine ≤ 2.5 g/dl
  • 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 as noted below:

    • Alkaline Phosphatase

      • ≤ ULN - eligible
      • > 1x but ≤1.5x ULN - eligible
      • > 2.5x but ≤ 5x ULN - eligible
      • > 5x ULN - ineligible
    • AST or ALT

      • ≤ ULN - eligible
      • > 1x but ≤1.5x ULN - eligible
      • > 2.5x but ≤ 5x ULN - ineligible
      • > 5x ULN - ineligible
  • 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 ≥ 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 post-prostatectomy androgen ablation within 6 months of protocol therapy.
  • 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 (allergic reaction or systemic fungal infection)
  • Pre-existing Grade ≥ 1 peripheral neuropathy
  • Patients with a history of a hypersensitivity reaction to products containing Polysorbate 80 (Tween 80)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669162

Contacts
Contact: Marilyn Labinski, RN 913-588-4254 mlabinski@kumc.edu
Contact: Christopher Baierl, BS 913-588-4721 cbaierl@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Parvesh Kumar, MD         
Sub-Investigator: Peter Van Veldhuizen, MD         
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Parvesh Kumar, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00669162     History of Changes
Other Study ID Numbers: 12313
Study First Received: April 24, 2008
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Goserelin
Docetaxel
Bicalutamide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 27, 2014