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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	December 10, 2008
Last Updated Date	December 11, 2008
Start Date ^†	March 2008
Current Primary Outcome Measures ^† (submitted: December 11, 2008)	Estimate Grade 3 or greater genitourinary and gastrointestinal toxicity [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00807820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: December 11, 2008)	MRI/MRS [ Time Frame: One year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy
Official Title ^†	Phase I Study of Targeting Dominant Intraprostatic Lesion Using Functional MR Spectroscopy and High Dose Rate Brachytherapy
Brief Summary	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.
Detailed Description
Study Phase	Phase I
Study Type ^†	Observational
Study Design ^†	Case-Only, Prospective
Condition ^†	Prostate Cancer
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Recruiting
Enrollment ^†	56
Completion Date
Primary Completion Date
Eligibility 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
Gender	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00807820
Responsible Party	Jean Pouliot, M.D., University of California, San Francisco. Radiation Oncology
Secondary IDs ^††	Grant: PC030909
Study Sponsor ^†	University of California, San Francisco
Collaborators ^††	Department of Defense
Investigators ^†
Information Provided By	University of California, San Francisco
Verification Date	December 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.