PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Condition(s) targeted: Prostate Cancer

Intervention: zoledronate therapy (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Barbara Ann Karmanos Cancer Institute

Official(s) and/or principal investigator(s):
Ulka N. Vaishampayan, M.D., Principal Investigator, Affiliation: Karmanos Cancer Institute

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.

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Primary outcome: PET response rate in metastatic prostate cancer patients treated with zoledronate therapy.

Secondary outcome:

Evaluate the change in PSA after zoledronate therapy

Evaluate changes in bone scans

Changes in bone turnover markers

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States; Recruiting
Clinical Trials Office - Barbara Ann Karmanos Cancer Institute, Phone: 313-576-9372

Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills, Michigan 48334, United States; Recruiting
Ulka N. Vaishampayan, Phone: 313-576-8718

Starting date: September 2010
Last updated: November 1, 2011