Integrated 18F-labelled PSMA Project

NCT02691169 | Unknown Early Phase 1

• 1 other identifier: JNMP-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There are several new therapies available to treat men with advanced prostate cancer; however, the decision making tools needed to determine the best treatment for these patients are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being recognized as an important target for prostate cancer imaging and determining the most effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of these agents is 18F-DCFPyL. In this study the investigators will image men with advanced prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT) scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan) and clinical follow-up. In this way, the investigators will evaluate the benefit of using 18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with [F-18]-DCFPyL-related adverse events as assessed by CTCAE v4.0

  The safety of \[F-18\]-DCFPyL administration to participants will be assessed by measuring changes from baseline in vital signs (blood pressure, heart rate and oxygen saturation) on the day of injection and through documentation of any other reported adverse events for up to 3 days post-administration.

  Up to 3 days post [F-18]-DCFPyL Injection

• Extent of baseline disease on [F-18]-DCFPyL imaging compared to extent of baseline disease on conventional imaging in each participant as assessed by counting the total number of lesions on imaging prior to starting hormonal therapy

  The extent of baseline disease on \[F-18\]-DCFPyL imaging (total number of lesions) will be compared to the extent of baseline disease on conventional imaging (total number of lesions) to determine \[F-18\]-DCFPyL imaging sensitivity.

  At the time of initial imaging

Secondary Outcomes (1)

• Treatment response on [F-18]-DCFPyL imaging using EORTC criteria will be compared with treatment response on clinical follow-up according to PCWG2 criteria.

  1 year post hormonal therapy initiation

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

The subjects will receive the 18F-DCFPyL Injection (less than or equal to 9 mCi (333 MBq)) at visits 2 and 3.

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

18F-DCFPyL is a sterile diagnostic radiopharmaceutical used for PET imaging.

18F-DCFPyL Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Age ≥ 18 years and male
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Subjects starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone), within approximately 1-7 days of the baseline 18F-DCFPyL PET/CT.
• Prior docetaxel-based chemotherapy is permitted but not required
• Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:
• Rising PSA over a minimum 1-week interval
• Radiographic progression in soft tissue and/or bone
• Ongoing androgen deprivation
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Hemoglobin ≥ 90 g/L independent of transfusion
• Platelet count ≥100 x109/L
• Albumin ≥ 30 g/L
• Creatinine \< 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
• Potassium ≥ 3.5 mmol/L

You may not qualify if:

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
• Abnormal liver functions consisting of any of the following:
• Total Bilirubin ≥ 1.5 x ULN (except for subjects with documented Gilbert's disease)
• AST or ALT ≥ 2.5 x ULN (for subjects with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
• Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline
• Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 12 months
• Known brain metastasis
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of orally administered hormonal agents.
• Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.0) grade of ≤ 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
• Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of the 18F-DCFPyL administration
• Condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
• Not willing to comply with the procedural requirements of this protocol

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Katherine Zukotynski, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Katherine Zukotynski

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 25, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: October-December 2017

Locations

CA (1)