## Protocol Section
### Identification Module
**NCT ID:** NCT00310479

**Brief Title:** Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

**Official Title:** Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

#### Organization Study ID Info
**ID:** GU-6-0062 / 22281
#### Organization
**Class:** OTHER
**Full Name:** AHS Cancer Control Alberta
### Status Module
#### Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-02-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-02-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Start Date
**Date:** 2006-06

**Status Verified Date:** 2012-03

#### Study First Post Date
**Date:** 2006-04-04
**Type:** ESTIMATED
**Study First Submit Date:** 2006-04-03
**Study First Submit QC Date:** 2006-04-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Cross Cancer Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** AHS Cancer Control Alberta

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.

**Detailed Description:** The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- Magnetic Resonance Imaging

- prostate cancer imaging

- 3T MRS

- functional imaging

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 16

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Magnetic Resonance Spectroscopy (3Tesla)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** characteristic metabolic pattern of prostate cancer at 3Tesla

#### Secondary Outcomes

**Measure:** specificity, accuracy, NPV

**Measure:** PPV of MRS in the detection of prostate cancer

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically verified prostate cancer
* Patient has opted for surgery
* Low risk prostate cancer PSA \<1 0, Gleason \< 7, Stage \< T2b
* No contraindication to MR scanning
* No prior history of malignancy
* Fit for surgery

Exclusion Criteria:

* Nonbiopsied lesion
* Intermediate or high risk prostate cancer
* Unfit for surgery
* Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)

**Minimum Age:** 40 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Edmonton

**Country:** Canada

**Facility:** Cross Cancer Institute

**State:** Alberta

**Zip:** T6G 1Z2

#### Overall Officials

**Official 1:**

**Affiliation:** AHS Cancer Control Alberta

**Name:** Matthew Parliament, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M11910

- Name: Mitral Valve Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
