Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy - Full Text View

Sponsors and Collaborators:	University of California, San Francisco Department of Defense
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00807820

Purpose

This is a phase I study to evaluate the feasibility and safety of using MRI/MRS to identify the dominant intraprostatic lesion (DIL) and to selectively boost the lesion using inverse planned high dose rate (HDR) brachytherapy.

The main objective is to exploit the ability of MRI/MRS to identify cancer regions within the prostate or the dominant intraprostatic lesions (DIL). The imaging data will be combined with the treatment planning CT images to define a treatment plan that will boost the dose delivered to the DIL up to 150% of the prescribed dose. Dose to the whole prostate and the dose delivered to adjacent organs will not change. This is accomplished by using inverse treatment planning software that can focus normally occuring high dose regions within the target volume to coincide with the DIL.

After enrollment, each patient will have a MRI/MRS before starting treatment. Hormonal therapy and external beam radiotherapy will be given based on current standard of practice. During HDR brachytherapy, information about the location of tumor within the prostate will be used to design the brachytherapy treatment plan. We will try to increase dose to DIL by conincide existing high dose region on DIL using inverse planning software. Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the deivery of brachytherapy will not change from our current practice. After the treatment, each patient will remain on study and follow for 12 months and treatment toxicity will be evaluated. A two-stage study design will be applied with a stopping rule for safety. Once a patient comes off study he will be routinely followed for disease outcome and any late toxicities.

Condition	Phase
Prostate Cancer	Phase I

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Phase I Study of Targeting Dominant Intraprostatic Lesion Using Functional MR Spectroscopy and High Dose Rate Brachytherapy

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Estimate Grade 3 or greater genitourinary and gastrointestinal toxicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

MRI/MRS [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	56
Study Start Date:	March 2008

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All patient who are candidate for prostate HDR brachytherapy will be offered this protocol

Criteria

Inclusion Criteria:

Patient must be a candidate for HDR prostate brachytherapy
Patient must be able to have MR scan
Patient must have a visible DIL on MRS
Patient has signed the protocol consent form
No prior pelvic or prostate radiation or chemotherapy for any reason
Induction hormonal therapy beginning ≤ 120 days prior to study entry is acceptable only if there is a MRI/MRS done prior to starting hormonal therapy
Prostate specific antigen prior to any (hormonal) therapy must be ≤ 20 ng/ml

One of the following combinations of factors:

Clinical stage T2a-2b, Gleason score 2-6 and PSA ≥ 10 but ≤ 20
Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20
Clinical stage T2a-T3b, Gleason score 7-10 and PSA ≤ 20

Exclusion Criteria:

Patient with hip prosthesis
Patient with pacemaker
Patient with history of radical surgery for prostate
Patient with claustrophobia
Patient with metal in body not safe for MR
Stage T4 disease
Lymph node involvement (N1)
Evidence of distant metastases (M1)
Previous hormonal therapy beginning > 120 days prior to registration
Hormonal therapy prior to MRI/MRS

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807820

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143-1708
Contact: Tracy Diep, B.A. 415-353-9855 tDiep@RadOnc.UCSF.Edu
Contact: Marilyn Robinson, B.A. (415) 353-4294 mrobinson@radonc.ucsf.edu
Principal Investigator: Jean Pouliot, Phd.
Principal Investigator: Mack Roach, M.D.
Sub-Investigator: I-Chow Hsu, MD.

Sponsors and Collaborators

University of California, San Francisco

Department of Defense

More Information

UCSF Radiation Oncology, Research and Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, San Francisco. Radiation Oncology ( Jean Pouliot, M.D. )
Study ID Numbers:	H11386-24294, Grant: PC030909
Study First Received:	December 10, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00807820
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009