Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00023829
First received: September 13, 2001
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may stop the adrenal glands from producing androgens. Giving radiation therapy with hormone therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery and be an effective treatment for stage II or stage III prostate cancer. It is not yet known if radiation therapy combined with hormone therapy is more effective than either radiation therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer. (Hormone therapy alone group closed as of 12/9/2002.)

PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in treating patients who have stage II or stage III prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: releasing hormone agonist therapy
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From the date of randomization to the date of death due to any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-Free Survival [ Time Frame: From the date of randomization to the date of first documented local progression or distant failure ] [ Designated as safety issue: No ]
  • Distant Failure [ Time Frame: From the date of randomization to the date of frist documented metastatic disease ] [ Designated as safety issue: No ]
  • Biochemical Failure (detectable PSA) [ Time Frame: From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: August 2001
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LH-RH agonist plus radiation therapy
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
Drug: bicalutamide Drug: flutamide Drug: releasing hormone agonist therapy Procedure: adjuvant therapy Radiation: radiation therapy
Active Comparator: Radiation therapy alone
Radiation therapy alone to 63.0 - 66.6 Gy
Procedure: adjuvant therapy Radiation: radiation therapy
Active Comparator: LH-RH agonist alone
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
Drug: bicalutamide Drug: flutamide Drug: releasing hormone agonist therapy Procedure: adjuvant therapy

Detailed Description:

OBJECTIVES:

  • Compare the overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure in patients with high-risk stage II or III prostate cancer treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy alone.
  • Compare the qualitative and quantitative toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10 ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm III closed to accrual as of 12/9/2002.)

  • Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the first day of radiotherapy, patients also receive hormonal therapy comprising a luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.
  • Arm II: Patients undergo radiotherapy as in arm I.
  • Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • T2-3, N0, M0
    • No metastatic disease
  • High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the following OR Gleason score < 7 and ≥ 2 of the following:

    • Preoperative PSA > 10 ng/mL
    • Positive surgical margins
    • Seminal vesicle invasion
  • Preoperative PSA ≤ 40.0 ng/mL
  • Postoperative PSA ≤ 0.2 ng/mL
  • Negative lymph node status by lymph node sampling or dissection

    • If lymph node status is unknown, must have < 5% risk of involvement by Roach formula

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 130,000/mm^3
  • Hemoglobin ≥ 11.4 g/dL

Hepatic:

  • ALT ≤ 3 times normal

Renal:

  • Creatinine ≤ 2.5 mg/dL

Other:

  • No other prior or concurrent invasive malignancy within the past 5 years except superficial nonmelanoma skin cancer
  • No other major medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 5 years since prior chemotherapy

Endocrine therapy:

  • At least 60 days since prior finasteride
  • At least 90 days since prior testosterone
  • Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within the past 10 months (must switch to study ablation therapy OR discontinue therapy if randomized to receive radiotherapy only)

Radiotherapy:

  • No prior radiotherapy to the pelvis
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • No prior orchiectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023829

Locations
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Radiation Therapy Oncology Group
NCIC Clinical Trials Group
Investigators
Study Chair: Richard K. Valicenti, MD Kimmel Cancer Center (KCC)
Study Chair: Richard Choo, MD Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00023829     History of Changes
Other Study ID Numbers: RTOG-P-0011, CDR0000068868, RTOG-DEV-1037, CAN-NCIC-PR9
Study First Received: September 13, 2001
Last Updated: November 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage III prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Bicalutamide
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014