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Can a better scan spot hidden prostate cancer?
NCT ID NCT00588185
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study is testing whether two types of PET scans can better detect where prostate cancer has spread in the body. About 300 men with prostate cancer that is getting worse will receive injections of a radioactive tracer and then be scanned. The goal is to see if these scans are more accurate than standard imaging like CT or bone scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2003
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Salivary Gland Cancers Inclusion Criteria: * Histologically proven diagnosis of salivary cancer with AR expression detected by immunohistochemistry * Measurable disease as defined by RECIST v1.1 criteria * Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease. * Age ≥ 18 years * ECOG performance status 0 or 1 * AST/ALT \< 3xULN * No prior AR-targeted therapy (Exception: AR-targeted therapy administered in the adjuvant setting and with disease recurrence more than 6 months since treatment completion) Exclusion Criteria: * Uncontrolled or untreated brain metastases * Class 3 or 4 congestive heart failure * Uncontrolled hypertension (systolic BP \>170 mmHg or diastolic BP \>105 mmHg at screening) * Vascular or ischemic event within 6 months of study registration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Consent Only)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Consent Only)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Consent only)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Consent only)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Consent Only)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Consent only)
RECRUITINGHarrison, New York, 10604, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?