Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer

NCT00653757 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000588847P30CA015083390-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (7)

• Toxicity

• Survival rates

• Freedom from biochemical relapse rates

• Local control rates

• Distant failure rates

• Biochemical freedom from failure rates

• Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance

Secondary Outcomes (2)

• Obstructive urinary symptoms

• Sexual health as assessed by inventory questionnaire

Interventions

goserelin acetate DRUG

leuprolide acetate DRUG

image-guided radiation therapy RADIATION

intensity-modulated radiation therapy RADIATION

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed prostate cancer * Stage I-IV disease (T1-4, N0-1, M0) * No evidence of distant metastases (M0) on physical examination or bone scan PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 10.0 g/dL * WBC ≥ 3,000/mcL * Platelet count ≥ 90,000/mm * AST \< 2 times the upper limit of normal * No allergy to leuprolide acetate or goserelin PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin; Leuprolide; Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated

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)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Steven E. Schild, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 7, 2008
• Study Start: March 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2007
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

US (1)