Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments zoledronate therapy, pet scan
Sponsor Barbara Ann Karmanos Cancer Institute
Collaborator Department of Defense
Start date September 2010
End date August 2013
Trial size 11 participants
Trial identifier NCT01205646, WSU 2006-066

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
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.
zoledronate therapy Zometa
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
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.

Primary Outcomes

Measure
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
time frame: Within 3 weeks

Secondary Outcomes

Measure
Evaluate the Change in PSA After Zoledronate Therapy
time frame: Four weeks after initiating Zoledronate therapy
Evaluate Changes in Bone Scans
time frame: Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers
time frame: Four weeks after initiating zoledronte therapy

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer
Principal investigator Ulka N. Vaishampayan, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute.