[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer; Localized Prostate Cancer
Intervention: [18F] DIHYDRO-TESTOSTERONE (Drug); PET scan (Device); MRI (Device); Blood draw (Other)
Phase: Phase 1
Status: Recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Joseph Osborne, MD, PhD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Overall contact: Daniel Spratt, MD, Phone: 212-639-6531
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.
Clinical Details
Official title: Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: increase in standardize uptake values (SUV) between the second and third FDHT scans
Secondary outcome: correlate AR expression to FDHT uptake
Eligibility
Minimum age: 21 Years.
Maximum age: 79 Years.
Gender(s): Male.
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)
- 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
- Karnofsky performance status ≥ 70
- 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.
Locations and Contacts
Daniel Spratt, MD, Phone: 212-639-6531
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting Daniel Spratt, MD, Phone: 212-639-6531
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: November 2014
Last updated: August 18, 2015
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