A Phase 1/2 interventional study of goserelin acetate and leuprolide acetate in Prostate Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression.
After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Pathologically confirmed prostate cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
Obstructive urinary symptoms
Sexual health as assessed by inventory questionnaire
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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