Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
21–79
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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:
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.
Clareo Health | [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
