An interventional study of Proton Beam Radiation Therapy and Quality-of-Life assessment in Prostate Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Treatment
RATIONALE: 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 clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
V. To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
OUTLINE:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 300 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
Procedure: Proton Beam Radiation Therapy · Other: Quality-of-Life assessment · Other: Questionnaire Administration
Proton Beam Radiation Therapy
Quality of Life Assessment
Questionnaire Administration
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Time frame: 5 years
Acute toxicity as assessed by NCI CTC Version 3.0
Time frame: 90 days
Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Time frame: 90 days
Biochemical/clinical progression-free survival
Time frame: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine