RecruitingNot ApplicableNCT00588185

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

300 participants

Start Date

Feb 1, 2003

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.

Eligibility

Sex: MALE

Inclusion Criteria7

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 Criteria3

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

Interventions

DRUG[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

Registered patients will undergo PET scanning using either FDHT alone or FDG and FDHT depending on the clinical question being asked. Scans will be performed serially at baseline, week 4, week 12, and every 12 weeks of treatment up to a maximum of 8 FDHT/FDG scan set in a 12 month period (maximum 40 scan sets per lifetime) unless the therapeutic protocol or scientific rationale of the therapeutic drug being applied specifically dictates an alternative schedule. Patients may have blood drawn for the purposes of establishing the pharmacokinetics of FDHT and may also undergo an initial dynamic scan if further pharmacokinetic information is warranted, followed by a standard whole body image. If no further pharmacokinetic information is warranted, then patients will only undergo a standard whole body image.