PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

NCT01205646 | Completed Results DMC

• 1 other identifier: WSU 2006-066
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Keywords

prostate cancer; metastatic; zoledronate; zometa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Change in PSA After Zoledronate Therapy

  Four weeks after initiating Zoledronate therapy

• Change in Bone Scans

  Four weeks after initiating zoledronate therapy

• Changes in Bone Turnover Markers

  Four weeks after initiating zoledronte therapy

Study Arms (1)

Zometa & PET Scans

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.

Drug: zoledronate therapy; Device: PET Scan

Interventions

zoledronate therapy 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.

Also known as: Zometa

Zometa & PET Scans

PET Scan 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.

Zometa & PET Scans

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• United States Department of Defense: collaborator

Study Sites (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Zoledronic Acid; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Ulka Vaishampayan, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

vaishamu@karmanos.org

(313) 576-8718

Study Officials

• Ulka N. Vaishampayan, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2015
• Last Updated: April 12, 2019
• Results First Posted: June 6, 2014

Record last verified: 2019-04

Locations

US (2)