New York, New York 10065


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

00-095


NCT ID:

NCT00588185


Secondary ID:


Study Acronym:


Brief Title:

[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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Male


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Michael Morris, M.D., Ph.D.
Principal Investigator
Memorial Sloan Kettering Cancer Center
Primary Contact:Michael Morris, M.D., PH.D.
646-422-4469

Study Dates

Start Date:February 2003
Completion Date:February 2020
Completion Type:Anticipated
Primary Completion Date:February 2020
Primary Completion Type:Anticipated
Verification Date:March 2019
Last Changed Date:March 11, 2019
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary Outcome
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.
Time Frame:Baseline, 4 weeks and 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The kinetics, metabolism, and biodistribution will be assessed.
Time Frame:Baseline. 4 weeks and 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To correlate the accumulation of 18FDHT to 18FDG.
Time Frame:2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor
Time Frame:2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:relationship between FDHT uptake and tumor diffusivity
Time Frame:2 years
Safety Issues:False
Description:assessed by MRI.
Outcome Type:Secondary Outcome
Measure:relationship between FDHT uptake and tissue analyses
Time Frame:2 years
Safety Issues:False
Description:of AR expression

Study Interventions

Intervention Type:Drug
Name:[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-
Description: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
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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