No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Male
Study type
Interventional
Purpose
Diagnostic
Participants needed
300 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with progressive prostate cancer to see if certain PET scans can better identify where the cancer has spread in their body. Participants will undergo imaging tests to track their cancer's progression.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate cancer.
I have evidence that my cancer is progressing.
I have rising PSA levels measured at specified intervals.
I have visible lesions from imaging tests.
I can provide informed consent.
You may not be able to join if
I have had a severe allergic reaction to FDHT or FDG.
My liver function tests are severely abnormal.
My kidney function is severely impaired.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Locations
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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 t…
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.
Contacts
Heiko Schoder, MD
212-639-8001
CONTACT
Michael Morris, MD, PhD
646-422-4469
CONTACT
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