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

NCT ID: NCT01132599

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31

Brief 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.

Detailed 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

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

C-11 choline

Intervention Type: DIETARY_SUPPLEMENT

18F-fluoromethylcholine

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael O'Doherty, MD

Role: PRINCIPAL_INVESTIGATOR

St. Thomas' Hospital

Locations

St. Thomas' Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CRUK-CR0701-21

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2008-004828-23

Identifier Type: -

Identifier Source: secondary_id

CDR0000674024

Identifier Type: -

Identifier Source: org_study_id