Computer Planned Radiation Therapy in Treating Patients With Prostate Cancer

NCT00003104 | Completed Phase 2

• 3 other identifiers: 97-064CDR0000065838NCI-H97-0006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: This phase II trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer

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 proven intermediate prognostic risk (T1-T2) adenocarcinoma of the prostate * Previously untreated (except for hormonal therapy) * PSA levels greater than 10 ng/mL and Gleason scores no greater than 6 OR * PSA levels no greater than 10 ng/mL and Gleason scores at least 7 * Patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation * No evidence of distant metastases * No regional lymph node involvement PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No major medical illness * No psychosis * No metallic pelvic prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * See Disease Characteristics * Prior neoadjuvant antiandrogen therapy allowed Radiotherapy: * No prior radiotherapy * No prior pelvic irradiation Surgery: * No prior radical surgery for carcinoma of the prostate

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

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

• Michael J. Zelefsky, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1997
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

US (1)