PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01205646
First received: September 17, 2010
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: zoledronate therapy
Device: PET Scan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. [ Time Frame: Within 3 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate the Change in PSA After Zoledronate Therapy [ Time Frame: Four weeks after initiating Zoledronate therapy ] [ Designated as safety issue: No ]
  • Evaluate Changes in Bone Scans [ Time Frame: Four weeks after initiating zoledronate therapy ] [ Designated as safety issue: No ]
  • Changes in Bone Turnover Markers [ Time Frame: Four weeks after initiating zoledronte therapy ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 2010
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205646

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Ulka N. Vaishampayan, M.D. Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Ulka Vaishampayan, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01205646     History of Changes
Other Study ID Numbers: WSU 2006-066
Study First Received: September 17, 2010
Results First Received: April 18, 2014
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Barbara Ann Karmanos Cancer Institute:
prostate cancer
metastatic
zoledronate
zometa

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014