PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: PET Scan; Drug: zoledronate therapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01205646

WSU 2006-066

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Zometa & PET Scans

Experimental group

Description:

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.

Treatment:

Device: PET Scan

Drug: zoledronate therapy