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

NCT01132599 | Withdrawn Phase 2

• 3 other identifiers: CDR0000674024CRUK-CR0701-21EUDRACT-2008-004828-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline

Secondary Outcomes (2)

• 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

• Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0

Interventions

C-11 choline DIETARY_SUPPLEMENT

18F-fluoromethylcholine RADIATION

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (1)

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluoromethylcholine

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

• Michael O'Doherty, MD

  St. Thomas' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

GB (1)