PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

NCT ID: NCT01205646

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-08-31

Brief Summary

The primary goal for this trial is to assess the change in PET scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. It has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. Researchers propose to evaluate the change in the uptake value of FMAU PET scan after the zoledronate therapy. It has been demonstrated that FMAU PET scans can successfully demonstrate and detect bony metastatic sites in prostate cancer.

In addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (PSA) in the patient as well as outcome of bone scans.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Zometa & PET Scans

Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Group Type: EXPERIMENTAL

zoledronate therapy

Intervention Type: DRUG

Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan

Intervention Type: DEVICE

2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Interventions

zoledronate therapy

Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

Intervention Type: DRUG

PET Scan

2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Intervention Type: DEVICE

Other Intervention Names

Zometa

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of prostate cancer
• Evidence of metastatic disease by radiologic criteria
• Bone scan within 4 weeks of starting therapy
• Creatinine within 2 weeks of registration, calculated creatinine clearance > 60ml/min.
• Minimum life expectancy of 6 months
• Willingness to have pre-therapy PET scans performed within 2 weeks after registration and post therapy PET scan performed within 1 week after dose of Zometa (a total of 3 PET scans required)
• Calculated creatinine clearance > 50ml/min.
• No prior Zoledronate therapy
• Patients must have disease progression despite testosterone suppression (level<50ng/ml); progression can be by rising PSA ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on CT scan.
• No concomitant systemic therapy for metastatic prostate cancer is allowed except LHRH analogue should be continued if necessary to maintain testosterone suppression.
• No concomitant radiation therapy
• Prior RT is allowed if completed at least 2 weeks prior to registration.
• Presence of measurable or evaluable disease
• If RT has been administered, disease outside the RT port is required.
• Willingness to sign informed consent.
• Registration and willingness to sign informed consent for separate PET protocol 2335 that describes the PET scan procedure.
• Patients must have good oral hygiene which includes having a recent dental evaluation

Exclusion Criteria

• Patients who are unable to swallow
• Patients with dental cavities that are likely to need dental extraction or root canal treatment as management

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ulka Vaishampayan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulka N. Vaishampayan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Countries

United States

Other Identifiers

WSU 2006-066

Identifier Type: -

Identifier Source: org_study_id