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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Hormone Refractory Prostate Cancer

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Trial Information

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

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

4. Serum testosterone level < 50 ng/ml. Castrate testosterone levels must be from
orchiectomy or current therapy with luteinizing hormone-releasing hormone agonist.

5. 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.

6. A rise in PSA following anti-androgen drug withdrawal, above the last PSA value
before withdrawal.

7. Patient is under the care of a medical oncologist and has agreed to treatment with a
docetaxel-based chemotherapy regimen that is consistent with current standards of

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 study protocol (e.g., SWOG S0421: Addition of atrasentan to
docetaxel/prednisone). Not allowed: concurrent radiotherapy or radioisotope therapy
(e.g., strontium). Other: Prior radiotherapy or radioisotope therapy must be >12
weeks since last treatment.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PSA Outcome

Outcome Time Frame:

12 week post-chemotherapy

Safety Issue:


Principal Investigator

Sandi A Kwee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Queen's Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

July 2013

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Hormone Refractory Prostate Cancer
  • Castrate Resistant Prostate Cancer
  • Prostatic Neoplasms



The Queen's Medical CenterHonolulu, Hawaii  96813