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Trial record 2 of 23 for:    ZD4054

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119118
Recruitment Status : Terminated
First Posted : May 7, 2010
Results First Posted : April 29, 2013
Last Update Posted : November 21, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that has spread to the bones by using new imaging techniques. In particular, this study will use fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI scans to look for changes in bone metastasis after ZD4054 therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ZD4054 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Response Assessment With PET/MRI Imaging in Patients With Metastatic Prostate CAncer to Bone Treated With ZD4054
Study Start Date : April 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
ZD4054 + multimodal PET/MRI imaging
Drug: ZD4054
All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 weeks followed by the final NaF and FDG-PET/CT and MRI acquisition (scan#3). After the final PET/MRI is obtained, patients will resume ZD4054 and be assessed for safety prior to each new cycle of therapy. Standard disease evaluation assessments will be conducted after cycle#3, and repeated after every third cycle (sooner if clinically indicated). Therapy will continue until radiographical/clinical disease progression or unacceptable toxicity

Primary Outcome Measures :
  1. The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans. [ Time Frame: Week 6 ]
    Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.

Secondary Outcome Measures :
  1. The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone. [ Time Frame: Week 6 ]
  2. The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone [ Time Frame: Week 6 ]
  3. Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone [ Time Frame: Week 6 ]
  4. Number of Subjects With PSA Response [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01119118

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United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Glenn Liu, M.D. University of Wisconsin, Madison
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison Identifier: NCT01119118    
Other Study ID Numbers: CO09805
NCI-2011-00736 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE/MEDICINE*H ( Other Identifier: UW Madison )
H-2009-0160 ( Other Identifier: Institutional Review Board )
First Posted: May 7, 2010    Key Record Dates
Results First Posted: April 29, 2013
Last Update Posted: November 21, 2019
Last Verified: March 2013
Keywords provided by University of Wisconsin, Madison:
castrate-resistant prostate cancer
bone metastasis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases