Clinical trial NCT02297386: [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Official title: Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Localized Prostate Cancer
Keywords: [18F] Dihydro-testosterone
PET Scan
MRI
14-185
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 3
Sex: MALE
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: increase in standardize uptake values (SUV) between the second and third FDHT scans
timeFrame: 1 year
Secondary outcomes:
measure: correlate AR expression to FDHT uptake
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Joseph Osborne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: