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 II trial comparing [11C]choline and [18F]choline for the imaging of metastatic prostate cancer

• Conditions: metastatic prostate cancer; MedDRA version: 12.1Level: LLTClassification code 10036909Term: Prostate cancer metastatic

• Registration Number: EUCTR2008-004828-23-GB
• Lead Sponsor: Cancer Research UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 55

Inclusion Criteria

1. Histologically proven prostate cancer

2. At least 4 new metastatic bone lesions, as identified by conventional imaging with bone scintigraphy

3. Either:
a) Treatment naive for prostate cancer
OR
b) Castration refractory prostate cancer [castrate will be defined as a testosterone level of <50 ng/dL (<2 nM)] with progressive disease (PD). PD will be defined by fulfilment of at least one of the following criteria:
• PSA progression defined as a rising PSA according to Prostate Cancer Working Group 2 (PCWG2) criteria
• Soft tissue disease progression defined by RECIST 1.1 (Eisenhauer E.A., et al., 2009)
• Bone disease progression defined by PCWG2 with two or more lesions on bone scan

These patients will either have previously known bone metastases on bone scintigraphy and are now progressing on LHRHa with or without maximum androgen blockade, or, will not previously have had known bone metastases

4. Life expectancy of at least 12 weeks

5. World Health Organisation (WHO) performance status of 0, 1, or 2

6. Haematological and biochemical indices within the ranges shown below performed within 24 hours prior to administration on Day 1 (Day -1 to Day 1).

Laboratory TestValue required
Haemoglobin (Hb) =9.0 g/dL
Platelet count =100 x 10(9)/L
Serum bilirubin =1.5 x upper limit of normal (ULN)
ALT and AST =2.5 x ULN (unless raised due to tumour when =5 x ULN is permissible)

7. 18 years or over

8. Written (signed and dated) informed consent and able to comply with study assessments and follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. For treatment naive patients any prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy, for treatment of prostate cancer

For castration refractory patients any prior radiotherapy, chemotherapy, or immunotherapy for treatment of prostate cancer

2. Patients with partners of child-bearing potential (unless they agree to take measures not to father children by using two forms of medically approved contraception during the trial)

3. Patients with the following conditions which would prevent compliance with the scanning protocol:
- Diabetes
- High levels of pain / discomfort
- Urinary incontinence

4. Major thoracic and/or abdominal surgery from which the patient has not yet recovered.

5. History of recent significant cardiac arrhythmia

6. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (NYHA)

7. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial

8. Participation or planned participation in any other interventional clinical trial, whilst taking part in this trial. Participation in an observational trial would be acceptable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified