Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

NCT00258466 | Withdrawn Phase 3 DMC

• 4 other identifiers: CDR0000447161P30CA022453WSU-D-2879WSU-HIC-047405MP4F
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

Secondary Outcomes (1)

• Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually

Interventions

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Stage I-III disease (T1-T3, N0, M0) * No clinical or radiographic evidence of metastasis * If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis * No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI * PSA ≤ 20 ng/mL * Gleason score ≤ 7 (if stage T3 , score must be \< 7) PATIENT CHARACTERISTICS: Performance status * Not specified Life expectancy * More than 10 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No other malignancy within the past 5 years except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Endocrine therapy * Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following: * Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide) * Anti-androgens (e.g., flutamide, bicalutamide) Radiotherapy * No prior pelvic irradiation Surgery * No prior radical prostatectomy

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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)

Therapeutics

Study Officials

• Jeffrey D. Forman, MD, FACR

  Weisberg Cancer Treatment Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 24, 2005
• Study Start: May 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 8, 2013

Record last verified: 2013-04