Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer (NCT00928252) | Clinical Trial Compass
CompletedPhase 1/2
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
United States25 participantsStarted 2009-06
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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.
What they're measuring
1
Metabolically Active Tumor Volume (MATV) Response
Timeframe: 21 to 98 days
2
Time to PSA Progression
Timeframe: 2 years
3
Proportional Hazards Regression Analysis of Time to PSA Progression
✕. 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.