Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

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.

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.

zoledronate therapy

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.

PET Scan

Ulka N. Vaishampayan, M.D.

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.

PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer

PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.

The change in PSA after zoledronate therapy using per cent change.

Change in bone scans using per cent change in SUVmax.

Changes in bone turnover markers using per cent change of BSAP and NTx

United States Department of Defense

Barbara Ann Karmanos Cancer Institute

Principal Investigator

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 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.

Zometa & PET Scans

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Ulka Vaishampayan, M.D.

PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.

All patients who had their PSA measured both before and after therapy.

The Change in PSA After Zoledronate Therapy

Change in Bone Scans

BSAP

Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer	NCT01205646	Prostate Cancer	zoledronate the... PET Scan	-	Barbara Ann Karmanos Cancer Institute
PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer	NCT01205646	Prostate Cancer	zoledronate the... PET Scan	-	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for zoledronate therapy