[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
1 other identifier
interventional
300
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Feb 2003
Longer than P75 for not_applicable prostate-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
April 9, 2026
April 1, 2026
24 years
December 26, 2007
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 4 weeks and 12 weeks
Secondary Outcomes (5)
The kinetics, metabolism, and biodistribution will be assessed.
Baseline. 4 weeks and 12 weeks
To correlate the accumulation of 18FDHT to 18FDG.
2 years
To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor
2 years
relationship between FDHT uptake and tumor diffusivity
2 years
relationship between FDHT uptake and tissue analyses
2 years
Study Arms (1)
1
EXPERIMENTAL\[18F\]-Fluoro-2-Deoxy-D-Glucose and -\[18F\] Dihydro-Testosterone
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Morris, M.D., Ph.D.
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 8, 2008
Study Start
February 1, 2003
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04