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

Primary Purpose

Prostate Cancer

Status

Withdrawn

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

C-11 choline

18F-fluoromethylcholine

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

St. Thomas' Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01132599

First Posted

May 26, 2010

Last Updated

February 27, 2012

Sponsor

Cancer Research UK

1. Study Identification

Unique Protocol Identification Number

NCT01132599

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Withdrawn

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Research UK

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage IV prostate cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

C-11 choline

Intervention Type

Radiation

Intervention Name(s)

18F-fluoromethylcholine

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael O'Doherty, MD

Organizational Affiliation

St. Thomas' Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Thomas' Hospital

City

London

State/Province

England

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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