Using PET scans to find spread of prostate cancer
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
This study is testing if special PET scans can help find out how far prostate cancer has spread in patients whose cancer is getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT00588185 on ClinicalTrials.gov |
What this trial studies
This study utilizes PET imaging with two radiotracers, [18F]-Fluoro-2-Deoxy-D-Glucose and [18F] Dihydro-Testosterone, to identify areas of abnormal metabolism in patients with progressive prostate cancer. The research aims to evaluate the effectiveness of these imaging techniques in detecting tumor spread and assessing treatment outcomes. By comparing the uptake of these tracers in relation to conventional imaging studies, the study seeks to provide a more accurate assessment of disease progression. Additionally, it will explore the relationship between FDHT accumulation and androgen receptor expression in available tumor samples.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed prostate cancer exhibiting progressive disease as indicated by imaging or rising PSA levels.
Not a fit: Patients with a history of severe allergic reactions to FDHT or FDG, or those with significant hepatic or renal impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and monitoring of prostate cancer progression, allowing for more tailored treatment strategies.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically confirmed prostate cancer. * Progressive disease manifest by either: * Imaging modalities: * Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or * Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart. * Visible lesions by either CT, bone imaging, or MRI consistent with disease. * Informed consent. Exclusion Criteria: * Previous anaphylactic reaction to either FDHT or FDG * Hepatic: Bilirubin \> 1.5 x upper limit of normal (ULN), AST/ALT \>2.5 x ULN, albumin \< 2 g/dl, and GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN * Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Morris, M.D., Ph.D. — Memorial Sloan Kettering Cancer Center
- Study coordinator: Michael Morris, M.D., PH.D.
- Phone: 646-422-4469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.