ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01119118
• Date of registration: 05/05/2010
• Primary sponsor: University of Wisconsin, Madison
• Public title: ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate Cancer
• Scientific title: Pharmacodynamic Response Assessment With PET/MRI Imaging in Patients With Metastatic Prostate CAncer to Bone Treated With ZD4054
• Date of first enrolment: April 2010
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01119118
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Glenn Liu, M.D.
• Affiliation: University of Wisconsin, Madison

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Men > 18 years of age.

2. Histologically proven adenocarcinoma of the prostate.

3. Presence of radiographic bone metastasis with at least one which is amenable to
serial imaging using MRI/PET imaging.

4. Patients must have evidence of progressive disease by either radiographic progression
or a rising PSA within 4 weeks prior to registration.

5. Patients must have had prior treatment with bilateral orchiectomy or other primary
androgen-deprivation therapy.

6. For patients previously treated with flutamide (Eulexin), Nilutamide (Nilandron), or
bicalutamide (Casodex): Patients must have discontinued flutamide > 4 weeks prior to
registration with continued evidence of progressive disease. For bicalutamide or
nilutamide, patients must have discontinued the drug > 6 weeks prior to registration
with evidence of progressive disease.

7. Prior therapy is permitted as long as it was given > 4 weeks prior to registration,
and evidence for disease progression is met.

8. Patients must not have had prior radiotherapy < 4 weeks prior to registration.

9. Prior use of bisphosphonates allowed only if started at least 12 or more weeks prior
to registration (can continue current dose/schedule while on study).

10. Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.

11. No concurrent use of estrogen, or estrogen-like agents

12. Patients must have adequate organ function

13. ECOG performance status 0-2.

Exclusion Criteria:

1. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and
phenobarbitone, St. John's Wort) within 2 weeks prior to start of study treatment.

2. Prior therapy with endothelin receptor antagonists or family history of
hypersensitivity to endothelin antagonists.

3. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder.

4. Stage II, III or IV cardiac failure (classified according to New York Heart
Association (NYHA) classification), myocardial infarction within 6 months prior to
study entry, or have left ventricular function (LVEF) below the institutional normal
limit.

5. QT interval corrected for heart rate (by Bazett's correction) (QTcB) >470 msec.

6. Previous history or presence of another cancer, other than prostate cancer or treated
squamous/basal cell carcinoma of the skin, within the last 5 years.

7. Major surgery within 6 weeks of registration.

8. Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is
allowed.

9. Inability to take or absorb oral medications.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: ZD4054

Primary Outcome(s)

To evaluate in identified target lesions a change in imaging parameters compared to baseline, after ZD4054 therapy, using multimodal positron emission tomography (PET) and magnetic resonant imaging (MRI) imaging [Time Frame: 6 months]

Secondary Outcome(s)

To correlate PSA response rate, changes in PSA velocity and PSA doubling time of subjects receiving ZD4054 to PET, MRI and combined PET/MRI imaging results [Time Frame: 6 months]

To document response to ZD4054 therapy with diffusion-weighted imaging (DWI)-magnetic resonant imaging (MRI) alone [Time Frame: 6 months]

To document response to ZD4054 therapy with Iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL)-MRI imaging alone [Time Frame: 6 months]

To document response to ZD4054 therapy with positron emission tomography (PET) imaging alone: 18F-Sodium Fluoride (NaF) and fluorodeoxyglucose (FDG)PET. [Time Frame: 6 months]

Secondary ID(s)

CO09805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca