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COMPLETEDPHASE1/PHASE2

Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

NCT00928252•Queen's Medical Center

Summary

The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.

Detailed Description

Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Provision of written informed consent.
•2. Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
•3. History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
•4. Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA \> 5.0 ng/ml.
•5. A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
•6. Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T.

Exclusion Criteria

•1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
•2. Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
•3. Patient weighs over 350 lbs (due to scanner weight limit).
•4. Clinical life expectancy \< 12 weeks.
•5. Participated in other radioactive drug studies where estimated total cumulative dose within 1 year is \> 0.05 Sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 Sievert for other organs.
•6. Concurrent Therapy. Allowed: Prior or concurrent chemotherapy, but must be \> 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.

Locations (1)

The Queen's Medical Center

Honolulu, Hawaii, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

June 1, 2016

Completion Date

June 1, 2016

Last Updated

August 14, 2017

Enrollment

ACTUAL participants

Conditions

Hormone Refractory Prostate Cancer

Interventions

IV fluorine-18 labeled methylcholine before PET/CT

DRUG

The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

NCT02955082

Hormone Refractory Prostate Cancer

View study

COMPLETEDPHASE2

BAY88-8223, Does Response Study in HRPC Patients

NCT00667199

Hormone Refractory Prostate CancerBone Metastases

View study

COMPLETEDPHASE2

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: August 14, 2017Data 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.

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Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

Inclusion Criteria

Exclusion Criteria

The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

BAY88-8223, Does Response Study in HRPC Patients

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients

PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Study of Patupilone in Prostate Cancer Patients Who Progress After Hormone Therapy and Docetaxel Chemotherapy