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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Michael O'Doherty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Thomas' Hospital

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CDR0000674024

NCT ID:

NCT01132599

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

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