Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre Identifier:
First received: June 24, 2009
Last updated: October 13, 2015
Last verified: October 2015
The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: IV administration of fluorine-18 fluorocholine followed by PET/CT imaging
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Queen's Medical Centre:

Primary Outcome Measures:
  • Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT [ Time Frame: Concurrent with PET Procedure ] [ Designated as safety issue: No ]
    The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.

Enrollment: 27
Study Start Date: June 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
Drug: IV administration of fluorine-18 fluorocholine followed by PET/CT imaging
Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.


Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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. Serum testosterone level < 50 ng/ml. Castrate testosterone levels must be from orchiectomy or current therapy with leutinizing hormone-releasing hormone agonist.
  5. Progressive disease evidenced by two consecutive rises in prostate specific antigen (PSA) above a nadir value, with the absolute value of the latest PSA > 2. 0 ng/ml.
  6. Patient will be undergoing a therapeutic intervention under the supervision of his treating physician (urologist, oncologist).

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 hormonal therapy; concurrent leuteinizing hormone releasing hormone (LHRH) agonist; prior surgery; prior or concurrent bisphosphonate. Not allowed: concurrent anti-androgen or secondary hormonal therapy, prior or concurrent chemotherapy, concurrent radiotherapy or radioisotope therapy (e.g., strontium). Other: Prior radiotherapy or radioisotope therapy must be > 12 weeks since last treatment.
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Please refer to this study by its identifier: NCT00928174

United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Queen's Medical Centre
National Institutes of Health (NIH)
Principal Investigator: Sandi A Kwee, MD The Queen's Medical Center
  More Information

No publications provided

Responsible Party: Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre Identifier: NCT00928174     History of Changes
Other Study ID Numbers: RA-2009-009, R21CA139687
Study First Received: June 24, 2009
Results First Received: October 1, 2014
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Queen's Medical Centre:
Androgen insensitive prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Cariostatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents processed this record on November 30, 2015