Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00288080
First received: February 6, 2006
Last updated: August 3, 2012
Last verified: August 2009
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: buserelin
Drug: docetaxel
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Drug: prednisone
Drug: triptorelin
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 4 years after registration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical control by prostate-specific antigen (PSA) ≥ 2 ng/mL above nadir at 4 years after registration [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: December 2005
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: flutamide
Given orally
Drug: goserelin acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.
Experimental: Arm II
Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.
Drug: bicalutamide
Given orally
Drug: buserelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: docetaxel
Given IV
Drug: flutamide
Given orally
Drug: goserelin acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: leuprolide acetate
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Drug: prednisone
Given orally
Drug: triptorelin
Patients receive luteinizing hormone-releasing hormone as a component of androgen suppression therap
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for approximately 8 weeks.

Detailed Description:

OBJECTIVES:

Primary

  • Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.

Secondary

  • Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.
  • Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.
  • Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.
  • Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.

  • Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
  • Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):

    • Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
    • Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2
    • Gleason score 8, PSA 20-150 ng/mL, and any T stage
    • Gleason score 7, PSA 20-150 ng/mL, and any T stage
  • Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry

    • Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
    • Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
  • PSA ≤ 150 ng/mL

    • Cannot have been obtained during any of the following time points:

      • 10-day period after prostate biopsy
      • After initiation of hormonal therapy
      • Within 30 days after discontinuation of finasteride
      • Within 90 days after discontinuation of dutasteride
  • No distant metastases by physical exam and bone scan

    • Equivocal bone scan findings allowed if plain films are negative

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,800/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
  • No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
  • No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • No transmural myocardial infarction within the past 6 months
  • No acute bacterial or fungal infection requiring intravenous antibiotics
  • No AIDS
  • No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
  • No existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

  • At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
  • At least 90 days since prior testosterone
  • Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
  • No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
  • No prior systemic chemotherapy for prostate cancer

    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
  • Intensity modulated radiotherapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288080

  Show 254 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Howard M. Sandler, MD University of Michigan Cancer Center
Investigator: Seth Rosenthal, MD Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
Investigator: Kenneth J. Pienta, MD, FACP University of Michigan Cancer Center
Investigator: Leonard G. Gomella, MD Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Publications:
Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00288080     History of Changes
Other Study ID Numbers: CDR0000462375, RTOG-0521
Study First Received: February 6, 2006
Last Updated: August 3, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Buserelin
Leuprolide
Triptorelin
Flutamide
Prednisone
Goserelin
Bicalutamide
Docetaxel
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Glucocorticoids
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 20, 2014