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PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer | Clinical Trials | Clareo Health

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PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Pilot Trial to Evaluate Change in Positron Emission Tomography Scanning (PET) as a Surrogate for Zoledronate (Zometa) Efficacy in Patients With Metastatic Prostate Cancer

NCT01205646•Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

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

Age

All ages

Sex

MALE

Healthy Volunteers

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.
+7 more criteria

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

Locations (2)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2015

Last Updated

April 12, 2019

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

zoledronate therapy

DRUG

PET Scan

DEVICE

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC