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[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

Page last updated: August 20, 2015

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