Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Cancer Research UK Phase II Trial to Compare [11C]Choline and [18F]Choline Each Given as a Single Administration Via Intravenous Injection for Imaging Patients With Metastatic Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01132599
• Other study ID #: CDR0000674024
• Secondary ID: CRUK-CR0701-21EU
• Status: Withdrawn
• Phase: Phase 2
• First received: May 26, 2010
• Last updated: February 27, 2012
• Start date: May 2010

Study information

• Verified date: February 2012
• Source: Cancer Research UK
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.

PURPOSE: This phase II trial is studying the side effects of C-11 choline and 18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in patients with metastatic prostate cancer.

Description:

OBJECTIVES:

• To compare C-11 choline to 18F-fluoromethylcholine using positron emission tomography and computed tomography imaging in their ability to detect metastatic prostate cancer.

• To compare the best early-phase (immediate) scanning of the two agents against the late-phase (one-hour delayed) 18F-fluoromethylcholine scanning in their ability to detect metastatic prostate cancer.

• To assess the safety of C-11 choline and 18F-fluoromethylcholine in these patients.

OUTLINE: Patients receive C-11 choline IV followed by a 10-minute dynamic positron emission tomography (PET) scan over the pelvis and then 5-minute scans at each bed position, from the pelvis to the base of the skull, (up to a maximum of 7 additional bed positions) lasting up to 45 minutes on day 1. Beginning 3 hours later, patients receive 18F-fluoromethylcholine IV followed by the same scanning protocol above lasting approximately 45 minutes. An additional 1-hour delayed PET-computed tomography (CT) scanning is then performed, which involves a 5-minute scan at each bed position from the pelvis to the base of the skull (up to a maximum of 7 bed positions) with 18F-fluoromethylcholine, lasting approximately 35 minutes. Patients then undergo treatment as per the normal standard of care following participation in this trial.

After completion of study treatment, patients are followed between 3-7 days.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer

• At least 4 metastatic lesions identified by conventional imaging with bone scintigraphy

• Treatment-naive disease

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy = 12 weeks

• Hemoglobin = 9.0 g/dL

• Platelet count = 100 x 10^9/L

• Serum bilirubin = 1.5 times upper limit of normal (ULN)

• ALT and AST = 2.5 times ULN (= 5 times ULN if due to tumor)

• Fertile patients must use two forms of effective contraception 2 weeks prior to, during, and for 6 months after completion of study therapy

• None of the following conditions that would prevent compliance with the study protocol:

• Diabetes

• High levels of pain/discomfort

• Urinary incontinence

• No history of recent significant cardiac arrhythmia

• No concurrent congestive heart failure or prior history of NYHA class III-IV cardiac disease

• No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy for the treatment of prostate cancer

• No major thoracic and/or abdominal surgery from which the patient has not yet recovered

• No concurrent anticancer therapy

• No concurrent hormone therapy

• No concurrent participation or planning to participate in another interventional clinical trial

• Concurrent participation in an observational trial allowed

• No other concurrent investigational drugs

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• C-11 choline

Radiation:
• 18F-fluoromethylcholine

Locations

Country	Name	City	State
United Kingdom	St. Thomas' Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline			No
Secondary	Identification of a true 5% difference in lesion detection between the best early-phase scanning, using either the 18F-fluoromethylcholine and C-11 choline, and late-phase scanning using 18F-fluoromethylcholine			No
Secondary	Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0			Yes