Clinical trial NCT00588185: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
Official title: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Progressive Prostate Cancer
[18F]-Fluoro-2-Deoxy-D-Glucose
[18F] Dihydro-Testosterone
Pet Imaging
Pet scan
00-095
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 300
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:

1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.

Eligibility 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

Primary outcomes:
measure: To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.
timeFrame: Baseline, 4 weeks and 12 weeks
Secondary outcomes:
measure: The kinetics, metabolism, and biodistribution will be assessed.
timeFrame: Baseline. 4 weeks and 12 weeks
measure: To correlate the accumulation of 18FDHT to 18FDG.
timeFrame: 2 years
measure: To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor
timeFrame: 2 years
measure: relationship between FDHT uptake and tumor diffusivity
timeFrame: 2 years
measure: relationship between FDHT uptake and tissue analyses
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Morris, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: