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Completed

NCT Number: NCT01205646

PET Scanning to Evaluate Zoledronate Efficacy in 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Zometa

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.

Primary outcomes

  1. PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.

    Time frame: Within 3 weeks

    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 outcomes

  1. The Change in PSA After Zoledronate Therapy

    Time frame: Four weeks after initiating Zoledronate therapy

    The change in PSA after zoledronate therapy using per cent change.

  2. Change in Bone Scans

    Time frame: Four weeks after initiating zoledronate therapy

    Change in bone scans using per cent change in SUVmax.

  3. Changes in Bone Turnover Markers

    Time frame: Four weeks after initiating zoledronte therapy

    Changes in bone turnover markers using per cent change of BSAP and NTx

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Sep 20, 2010
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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