Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00928252 |
Recruitment Status
:
Completed
First Posted
: June 25, 2009
Results First Posted
: August 14, 2017
Last Update Posted
: August 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hormone Refractory Prostate Cancer | Drug: IV fluorine-18 labeled methylcholine before PET/CT | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Received 18F-fluorocholine PET/CT
IV fluorine-18 labeled methylcholine before PET/CT
|
Drug: IV fluorine-18 labeled methylcholine before PET/CT
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Other Name: 18F-fluorocholine PET/CT
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- Metabolically Active Tumor Volume (MATV) Response [ Time Frame: 21 to 98 days ]Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
- Time to PSA Progression [ Time Frame: 2 years ]Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
- Proportional Hazards Regression Analysis of Time to PSA Progression [ Time Frame: Up to 15 week post-chemotherapy ]PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Provision of written informed consent.
- Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
- History of treatment by complete androgen blockade for greater than 3 months prior to enrollment
- 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.
- A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
- 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:
- 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.
- Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
- Patient weighs over 350 lbs (due to scanner weight limit).
- Clinical life expectancy < 12 weeks.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928252
United States, Hawaii | |
The Queen's Medical Center | |
Honolulu, Hawaii, United States, 96813 |
Principal Investigator: | Sandi A Kwee, MD | The Queen's Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre |
ClinicalTrials.gov Identifier: | NCT00928252 History of Changes |
Other Study ID Numbers: |
RA-2008-069 R21CA139687 ( U.S. NIH Grant/Contract ) |
First Posted: | June 25, 2009 Key Record Dates |
Results First Posted: | August 14, 2017 |
Last Update Posted: | August 14, 2017 |
Last Verified: | July 2017 |
Keywords provided by Sandi Kwee, Queen's Medical Centre:
Hormone Refractory Prostate Cancer Castrate Resistant Prostate Cancer |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones Choline Fluorides Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents Cariostatic Agents Protective Agents |