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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
bicalutamide
flutamide
releasing hormone agonist therapy
adjuvant therapy
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

0 Years - 120 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Sunnybrook Regional Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

LH-RH agonist plus radiation therapy

Radiation therapy alone

LH-RH agonist alone

Arm Description

Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy

Radiation therapy alone to 63.0 - 66.6 Gy

Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease-Free Survival
Distant Failure
Biochemical Failure (detectable PSA)

Full Information

First Posted
September 13, 2001
Last Updated
October 21, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00023829
Brief Title
Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Official Title
Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LH-RH agonist plus radiation therapy
Arm Type
Experimental
Arm Description
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years plus radiation therapy (RT) to 63.0 - 66.6 Gy
Arm Title
Radiation therapy alone
Arm Type
Active Comparator
Arm Description
Radiation therapy alone to 63.0 - 66.6 Gy
Arm Title
LH-RH agonist alone
Arm Type
Active Comparator
Arm Description
Luteinizing hormone-releasing hormone (LH-RH) agonist x 2 years
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Drug
Intervention Name(s)
releasing hormone agonist therapy
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From the date of randomization to the date of death due to any cause
Secondary Outcome Measure Information:
Title
Disease-Free Survival
Time Frame
From the date of randomization to the date of first documented local progression or distant failure
Title
Distant Failure
Time Frame
From the date of randomization to the date of frist documented metastatic disease
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K. Valicenti, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Choo, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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