[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer, Localized Prostate Cancer

In brief

The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for \[18F\] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost all prostate cancer cells. The investigators want to find out if we can find and monitor changes in cancer using a FDHT PET scan.

Key facts

Study ID

NCT02297386

Run by

Memorial Sloan Kettering Cancer Center

People needed

3

Starts

2014-11-01

Expected to finish

2018-08-01

Last updated by the study team

2018-08-06

Who can join

Age: 21 and older, up to 79. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male aged 21 years or older and below 80 years of age.
• Signed written informed consent and willingness to comply with protocol requirements.
• Histologically confirmed diagnosis of prostate cancer.
• Staging imaging workup including a baseline MRI of the prostate and pelvis performed at MSKCC.
• Baseline imaging to rule out distant metastatic disease (99mTc bone scan, NaF PET, total body MRI, or CT chest/abdomen/pelvis)
• Karnofsky performance status ≥ 70
• Clinical criteria required to be eligible:
• a. One of the following i.Pre-treatment PSA ≥10 ng/dL, OR ii. Clinical T-stage assessed by digital rectal exam of ≥T2a, OR ii . Radiographic ≥T3a on MRI, OR iv. Gleason score of ≥3+4=7 c. Visible intraprostatic tumor foci ≥1 cm in largest dimension on T2-weighted images based on initial pre-treatment MRI
• Physician recommendation of ADT.

You may not qualify if…

• Metastatic disease on standard staging imaging (beyond regional lymph node involvement).
• o Absence of metastatic disease (beyond regional lymph node involvement) as defined by a negative bone scan, NaF PET, CT chest/abdomen/pelvis, or total body MRI.
• Prior treatment of the prostate gland for malignant conditions (surgery, cryotherapy, radiotherapy, or photodynamic therapy).
• Physician prescription of androgen receptor antagonist therapy (examples: bicalutamide, flutamide, or enzalutamide) during time of protocol scans.
• o Note: ADT consists of chemical castration (i.e. degarelix) to remove endogenous DHT. Androgen receptor antagonists will bind to the androgen receptor and inhibit FDHT from binding.
• Patients receiving testosterone supplementation .
• Any contraindication to baseline MRI based on departmental MR questionnaire, or inability to cooperate for an MRI scan.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to FDHT.
• Hepatic laboratory values:
• Bilirubin >1.5 x ULN (institutional upper limits of normal)
• AST/ALT >2.5 x ULN
• Albumin <2 g/dL
• Creatinine >2.5 mg/dL
• Calcium >11 mg/dL
• Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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