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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Localized Prostate Cancer
• Intervention / Treatment: Device: MRI; Device: PET scan; Other: Blood draw; Drug: [18F] DIHYDRO-TESTOSTERONE

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: [18F] DIHYDRO-TESTOSTERONE PET; The diagnostic intervention of this study is the use of FDHT PET in localized prostate cancer. Patients will undergo a 30 minute dynamic scan of the pelvis followed by a whole body scan of approximately 30-minutes duration. The dynamic scan will be optional, but strongly encouraged. PET scanning will preferably be done on the GE Discovery STE PET/CT scanner or the equivalent generation of scanner. The PET scans are routinely "quantitative," that is corrected for attenuation and scatter and adjusted for system sensitivity and providing parametric images in terms of standardized uptake values (SUV) (= μCi found/gm tissue / μCi injected/gm body mass).

Device: MRI; Device: PET scan; Other: Blood draw; Drug: [18F] DIHYDRO-TESTOSTERONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase in standardize uptake values (SUV) between the second and third FDHT scans	Enrolling 15 patients will provide 80% power to detect a 33% increase in the mean uptake (from 6 to 8) between the 2nd and the 3rd scans.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlate AR expression to FDHT uptake	involves collecting formalin fixed paraffin embedded tissue from pre-treatment biopsy specimens to correlate androgen receptor (AR) expression to FDHT uptake. AR expression will be measured using RNA-seq and correlated with FDHT SUV values separately for each scan using Spearman's rank correlation.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Joseph Osborne, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): August 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (ESTIMATE): November 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: MRI; PET Scan; [18F] Dihydro-testosterone; 14-185
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone; Dihydrotestosterone
• Other Study ID Numbers: 14-185