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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297386
• Other study ID #: 14-185
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• [18F] DIHYDRO-TESTOSTERONE

Device:
• PET scan

• MRI

Other:
• Blood draw

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center