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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669162
Recruitment Status : Active, not recruiting
First Posted : April 29, 2008
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Radiation: Radiation Therapy Drug: Casodex and Zoladex (or Lupron) Phase 1 Phase 2

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669162

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Principal Investigator: Xinglei Shen, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center Identifier: NCT00669162     History of Changes
Other Study ID Numbers: 12313
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

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