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

Completed · Phase 1/Phase 2

Conditions studied: Hormone Refractory Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00928252

Run by

Queen's Medical Center

People needed

25

Starts

2009-06-01

Expected to finish

2016-06-01

Last updated by the study team

2017-08-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Queen's Medical Center — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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