Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance

NCT00796874 | Withdrawn DMC

• 2 other identifiers: CDR0000618738RPCI-I-124107
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed. PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in detecting cancer progression in patients with early-stage prostate cancer who are undergoing active surveillance.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer

Outcome Measures

Primary Outcomes (1)

• Prostate cancer progression measured by MRI while on active surveillance

  at 6 months, 1 year and than annualy for 5 years

Secondary Outcomes (1)

• Prostate cancer changes by MRI

  At 6months, 1 year and annually for 5 years

Interventions

active surveillance OTHER

Correlative Study

imaging biomarker analysis OTHER

Correlative Study

biopsy PROCEDURE

Tissue Removal

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Radiolical Medical Imaging

magnetic resonance imaging PROCEDURE

Radiolical Medical Imaging

magnetic resonance spectroscopic imaging PROCEDURE

Radiolical Medical Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Low-risk for progression, as evidenced by all of the following: * Tumor stage ≤ T2a * PSA ≤ 10 ng/mL * Gleason score ≤ 7 * Patients informed of treatment options and has already chosen to undergo active surveillance * No decision to stop active surveillance * No node-positive or metastatic disease PATIENT CHARACTERISTICS: * Willing to undergo MRI * Willing to undergo prostate biopsy * No contraindications to MRI that include, but not limited to, any of the following: * Claustrophobia * Anxiety * Presence of metal or shrapnel in the body * Pacemakers * Old tattoos with metal-based dye material * No contraindication to prostate biopsy * No medical conditions, as deemed by the PI or associates, that would prevent or limit the patient participation on the protocol that include, but not limited to, any of the following: * Severe coagulopathy * History of severe bleeding * Severe coronary artery disease * Other comorbid conditions that limit life expectancy to less than 2 years PRIOR CONCURRENT THERAPY: * No hormone therapy within the past year * No prior pelvic radiotherapy * No prior prostate resection including transurethral resection of prostate * Concurrent participation in other clinical studies (e.g., vitamin D, selenium) allowed provided active surveillance is continued

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting; Biopsy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Anurag K. Singh, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07