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

NCT00023829 | Completed Phase 3 DMC

• 3 other identifiers: RTOG-P-0011CDR0000068868CAN-NCIC-PR9
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of randomization to the date of death due to any cause

Secondary Outcomes (3)

• Disease-Free Survival

  From the date of randomization to the date of first documented local progression or distant failure

• Distant Failure

  From the date of randomization to the date of frist documented metastatic disease

• Biochemical Failure (detectable PSA)

  From the date of randomization to the date of developing a PSA of 0.5 ng/ml or greater over the entry PSA

Study Arms (3)

LH-RH agonist plus radiation therapy

EXPERIMENTAL

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

Radiation therapy alone

ACTIVE COMPARATOR

Radiation therapy alone to 63.0 - 66.6 Gy

Procedure: adjuvant therapy; Radiation: radiation therapy

LH-RH agonist alone

ACTIVE COMPARATOR

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

Drug: bicalutamide; Drug: flutamide; Drug: releasing hormone agonist therapy; Procedure: adjuvant therapy

Interventions

bicalutamide DRUG

LH-RH agonist alone; LH-RH agonist plus radiation therapy

flutamide DRUG

LH-RH agonist alone; LH-RH agonist plus radiation therapy

releasing hormone agonist therapy DRUG

LH-RH agonist alone; LH-RH agonist plus radiation therapy

adjuvant therapy PROCEDURE

LH-RH agonist alone; LH-RH agonist plus radiation therapy; Radiation therapy alone

radiation therapy RADIATION

LH-RH agonist plus radiation therapy; Radiation therapy alone

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NCIC Clinical Trials Group: collaborator

Study Sites (1)

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Flutamide; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Richard K. Valicenti, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

• Richard Choo, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: October 22, 2020

Record last verified: 2013-11

Locations

CA (1)