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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. Bilirubin >1.5 x ULN (institutional upper limits of normal)

2. AST/ALT >2.5 x ULN

3. 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.