Using Magnetic Resonance Imaging (MRI) to Guide Differential-Dose Prostate Brachytherapy

Sponsor

St. Luke's-Roosevelt Hospital Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01913197

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate to treat the entire gland. This is done because, in the past, it was impossible to know where the cancer was located within the prostate. Multiparametric magnetic resonance imaging (MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing lower doses to be delivered to the regions of the prostate without tumor while simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then be followed over two years and evaluated for toxicity. In addition, after two years they will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: An MRI-based technique to identify prostate cancer	Phase 1/Phase 2

Detailed Description

Prostate brachytherapy is a popular treatment for clinically localized prostate cancer. In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 85-95% at 5-10 years. However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas. Multiple studies have shown significant correlation between MRI abnormalities and radical prostatectomy specimens for determining size and location of cancer foci. MRI images have already begun to be incorporated into diagnostic and therapeutic procedures for prostate cancer on an experimental basis by other investigators. The images have been fused with real time TRUS to successfully perform targeted biopsies. In this study, we propose to use MRI images in the pre-treatment planning process to identify the tumors within the prostate prior to the brachytherapy and use these images to direct the dosimetry planning. The primary goal of this study is to decrease the chronic toxicities as assessed by the Common Toxicity Criteria Version 4.0 by decreasing the integral dose to the regions of the prostate which do not have tumor. A secondary goal is to increase the dose to the tumor(s) and demonstrate this ability while maintaining the urethral and other normal tissue doses. We also wish to perform dosimetric comparisons of the normal tissues and the tumor(s) when this technique is used compared to what would have been done if the patient had received a traditional implant. Finally, we propose to perform a prostate MRI followed by a biopsy to evaluate for persistent/recurrent disease at 2 years after treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Evaluation Magnetic Resonance Imaging (MRI)-Guided Differential-Dose Prostate Brachytherapy

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-implant MRI images and planning	Other: An MRI-based technique to identify prostate cancer

Arm

Intervention/Treatment

Experimental: Pre-implant MRI images and planning

Other: An MRI-based technique to identify prostate cancer

Outcome Measures

Primary Outcome Measures

Chronic toxicity as assessed by the Common Toxicity Criteria Version 4.0 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
PSA ≤ 15 ng/ml
Gleason sum on biopsy ≤ 6 or 3+4=7
Prostate volume ≤ 60 cc
Willing to continue follow-up for at least two years

Exclusion Criteria:

Prior hormone therapy
Prior radiotherapy
History of collagen vascular disease
History of inflammatory bowel disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Lukes-Roosevelt Hospital Center	New York	New York	United States

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Investigators

Principal Investigator: Ronald Ennis, MD, St. Luke's-Roosevelt Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT01913197

Other Study ID Numbers:

12-070

First Posted:

Jul 31, 2013

Last Update Posted:

Jan 6, 2017

Last Verified:

Jan 1, 2017

Keywords provided by St. Luke's-Roosevelt Hospital Center

Prostate Brachytherapy

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jan 6, 2017