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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ZD4054

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic, castrate-resistant prostate cancer, bone metastasis

Eligibility Criteria

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

Inclusion Criteria:

Men > 18 years of age.
Histologically proven adenocarcinoma of the prostate.
Presence of radiographic bone metastasis with at least one which is amenable to serial imaging using MRI/PET imaging.
Patients must have evidence of progressive disease by either radiographic progression or a rising PSA within 4 weeks prior to registration.
Patients must have had prior treatment with bilateral orchiectomy or other primary androgen-deprivation therapy.
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.
Prior therapy is permitted as long as it was given > 4 weeks prior to registration, and evidence for disease progression is met.
Patients must not have had prior radiotherapy < 4 weeks prior to registration.
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).
Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope.
No concurrent use of estrogen, or estrogen-like agents
Patients must have adequate organ function
ECOG performance status 0-2.

Exclusion Criteria:

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.
Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists.
History of past or current epilepsy, epilepsy syndrome, or other seizure disorder.
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.
QT interval corrected for heart rate (by Bazett's correction) (QTcB) >470 msec.
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.
Major surgery within 6 weeks of registration.
Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed.
Inability to take or absorb oral medications.

Sites / Locations

University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

ZD4054 + multimodal PET/MRI imaging

Outcomes

Primary Outcome Measures

The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.

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

The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.

The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone

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

Number of Subjects With PSA Response

Full Information

NCT ID

NCT01119118

First Posted

May 5, 2010

Last Updated

November 13, 2019

Sponsor

University of Wisconsin, Madison

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01119118

Brief Title

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

Official Title

Pharmacodynamic Response Assessment With PET/MRI Imaging in Patients With Metastatic Prostate CAncer to Bone Treated With ZD4054

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Prostate Cancer

Keywords

Metastatic, castrate-resistant prostate cancer, bone metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

ZD4054 + multimodal PET/MRI imaging

Intervention Type

Drug

Intervention Name(s)

ZD4054

Intervention Description

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 Measure Information:

Title

The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.

Description

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.

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.

Time Frame

Week 6

Title

The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone

Time Frame

Week 6

Title

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

Title

Number of Subjects With PSA Response

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men > 18 years of age. Histologically proven adenocarcinoma of the prostate. Presence of radiographic bone metastasis with at least one which is amenable to serial imaging using MRI/PET imaging. Patients must have evidence of progressive disease by either radiographic progression or a rising PSA within 4 weeks prior to registration. Patients must have had prior treatment with bilateral orchiectomy or other primary androgen-deprivation therapy. 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. Prior therapy is permitted as long as it was given > 4 weeks prior to registration, and evidence for disease progression is met. Patients must not have had prior radiotherapy < 4 weeks prior to registration. 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). Patient cannot have had prior Strontium 89, Samarium 153, or other radioisotope. No concurrent use of estrogen, or estrogen-like agents Patients must have adequate organ function ECOG performance status 0-2. Exclusion Criteria: 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. Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder. 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. QT interval corrected for heart rate (by Bazett's correction) (QTcB) >470 msec. 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. Major surgery within 6 weeks of registration. Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed. Inability to take or absorb oral medications.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn Liu, M.D.

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin Carbone Cancer Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25128349

Citation

Simoncic U, Perlman S, Liu G, Staab MJ, Straus JE, Jeraj R. Comparison of NaF and FDG PET/CT for assessment of treatment response in castration-resistant prostate cancers with osseous metastases. Clin Genitourin Cancer. 2015 Feb;13(1):e7-e17. doi: 10.1016/j.clgc.2014.07.001. Epub 2014 Jul 15.

Results Reference

derived

Links:

URL

https://cancer.wisc.edu/

Description

University of Wisconsin Carbone Cancer Center

Learn more about this trial

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

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