Clinical trial NCT01205646: PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
metastatic
zoledronate
zometa
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2010-09-20
Enrollment: 11
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
timeFrame: Within 3 weeks
Secondary outcomes:
measure: The Change in PSA After Zoledronate Therapy
timeFrame: Four weeks after initiating Zoledronate therapy
measure: Change in Bone Scans
timeFrame: Four weeks after initiating zoledronate therapy
measure: Changes in Bone Turnover Markers
timeFrame: Four weeks after initiating zoledronte therapy
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ulka N. Vaishampayan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: