Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01859689
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Withdrawn
Phase Phase 2
Start date March 2012
Completion date September 2013

See also
  Status Clinical Trial Phase
Completed NCT02217709 - Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer Phase 2
Completed NCT03077659 - Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer Phase 2
Recruiting NCT03624660 - Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer N/A
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Completed NCT00182052 - Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer Phase 3
Active, not recruiting NCT03511196 - Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Early Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer N/A
Terminated NCT03535675 - Muscadine Plus (MPX) In Men With Prostate Cancer Phase 3
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT02234921 - Pilot Study of DRibble Vaccine for Prostate Cancer Patients Phase 1
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT03686683 - Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer Phase 3
Active, not recruiting NCT03689699 - Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) Phase 1/Phase 2
Recruiting NCT04694924 - Prospective Prostate Cancer and Patient-reported Outcomes Registry
Active, not recruiting NCT04909294 - Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma N/A
Completed NCT02225925 - Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound N/A
Completed NCT01949519 - Docetaxel and Lycopene in Metastatic Prostate Cancer Phase 1
Completed NCT01433913 - Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery Phase 2