Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage II prostate cancer
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.
Detailed description
OBJECTIVES: Primary * To determine if MRI parameters (initial volume, number and location of image abnormalities, and MR spectroscopy) can improve the ability to stratify cancer progression risk in patients undergoing active surveillance for early-stage prostate cancer. Secondary * Determine if changes in non-invasive MRI, validated by MRI-guided biopsies, can accurately detect progression of prostate cancer. OUTLINE: Patients undergo prostate MRI scans and MRI-guided biopsies of suspicious lesions at baseline. Patients undergo conventional anatomic imaging followed by research biological imaging tests (e.g., magnetic resonance spectroscopic imaging and/or dynamic contrast-enhanced MRI). MRI are repeated at 6 months, 1 year, and then annually until initiation of definitive therapy or for a total of 5 years. Tissue biopsy with MRI guidance is done at baseline and annually or as clinically indicated based on change in rectal exam, PSA, or maybe done based on change in MR imaging (i.e., new MR lesion or significant change \[\> 25% increase\] in the size of a MR lesion). Blood samples are collected at baseline and periodically during study for PSA tests.
Interventions
OTHERactive surveillance
Correlative Study
Correlative Study
PROCEDUREbiopsy
Tissue Removal
PROCEDUREdynamic contrast-enhanced magnetic resonance imaging
Radiolical Medical Imaging
PROCEDUREmagnetic resonance imaging
Radiolical Medical Imaging
PROCEDUREmagnetic resonance spectroscopic imaging
Radiolical Medical Imaging
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate cancer progression measured by MRI while on active surveillance | at 6 months, 1 year and than annualy for 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Prostate cancer changes by MRI | At 6months, 1 year and annually for 5 years |
Outcome results
None listed