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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: zoledronate therapy; Device: PET Scan

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute Weisberg Cancer Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.; Other Names: Zometa; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.	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.	Within 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change in PSA After Zoledronate Therapy	The change in PSA after zoledronate therapy using per cent change.	Four weeks after initiating Zoledronate therapy
Change in Bone Scans	Change in bone scans using per cent change in SUVmax.	Four weeks after initiating zoledronate therapy
Changes in Bone Turnover Markers	Changes in bone turnover markers using per cent change of BSAP and NTx	Four weeks after initiating zoledronte therapy

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ulka N. Vaishampayan, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 17, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: prostate cancer; metastatic; zoledronate; zometa
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: WSU 2006-066