A Phase 2 interventional study of brachytherapy and image-guided radiation therapy in Adenocarcinoma of the Prostate, Recurrent Prostate Cancer and Stage I Prostate Cancer, sponsored by Jonsson Comprehensive Cancer Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
PRIMARY OBJECTIVES:
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.
III. To assess the potential value of multiparametric magnetic resonance imaging, including dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular tactographic imaging in predicting the development of equivocal disease (ED) following radiation treatment.
OUTLINE:
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Radiation: brachytherapy · Radiation: image-guided radiation therapy · Other: laboratory biomarker analysis
Undergo image-guided HDR brachytherapy
Also known as: low-LET implant therapy, radiation brachytherapy, therapy, low-LET implant
Undergo image-guided HDR brachytherapy
Correlative studies
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Time frame: 5 years
Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0
Time frame: 3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Time frame: 6 months
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Time frame: Up to 24 months
Changes in HR-QOL as determined by IIEF scores
Time frame: Up to 24 months
Changes in HR-QOL as determined by IPSS scores
Time frame: Up to 24 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center