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Status:

TERMINATED

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made ...

Detailed Description

OBJECTIVES: Primary * To compare disease-free survival rates in patients with high-risk localized adenocarcinoma of the prostate treated with androgen suppression therapy and radiotherapy with vs wi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the prostate
  • Localized (N0, M0) disease
  • No small cell or transitional cell carcinoma in the biopsy specimen
  • Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:
  • T stage ≥ 3a
  • Gleason score ≥ 8
  • Baseline prostate-specific antigen (PSA) \> 20 ng/mL
  • Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical oncologist
  • Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis
  • Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically negative by either needle aspirate or lymph node dissection
  • No metastases by chest x-ray and bone scan
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total bilirubin normal
  • Serum creatinine ≤ 1.5 times ULN
  • Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
  • Fertile patients must use effective contraception
  • No history of other malignancies, except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor with no evidence of disease for \> 5 years
  • No serious non-malignant disease resulting in a life expectancy of \< 10 years
  • No known hypersensitivity to any study medications
  • No existing peripheral neuropathy ≥ grade 2
  • No bilateral hip replacement prostheses
  • No contraindication to pelvic radiotherapy including, but not limited to, inflammatory bowel disease or severe bladder irritability
  • No medical condition that would contraindicate the study treatment regimen, including severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension
  • No other serious illness or psychiatric or medical condition that would preclude management of the patient according to the study, including active uncontrolled infection or significant cardiac dysfunction
  • PRIOR CONCURRENT THERAPY:
  • Prior androgen suppression therapy allowed provided it was initiated no more than 4 weeks prior to study entry
  • At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for benign prostatic hypertrophy
  • No prior cytotoxic anticancer therapy
  • No prior chemotherapy for carcinoma of the prostate
  • No prior surgical treatment for carcinoma of the prostate, except transurethral resection or bilateral orchiectomy
  • No prior pelvic radiotherapy
  • No concurrent nilutamide
  • No other concurrent investigational drugs
  • No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or radiotherapy)

Exclusion

    Key Trial Info

    Start Date :

    June 2 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 18 2011

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00651326

    Start Date

    June 2 2008

    End Date

    January 18 2011

    Last Update

    August 4 2023

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Tom Baker Cancer Centre

    Calgary, Canada, T2N 4N2

    2

    Cross Cancer Institute

    Edmonton, Canada, T6G 1Z2

    3

    Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Canada, L8V 5C2

    4

    BCCA - Cancer Centre for the Southern Interior

    Kelowna, Canada, V1Y 5L3