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Completed

NCT Number: NCT00928174

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Serum testosterone level < 50 ng/ml. Castrate testosterone levels must be from orchiectomy or current therapy with leutinizing hormone-releasing hormone agonist.
  • 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.
  • Patient will be undergoing a therapeutic intervention under the supervision of his treating physician (urologist, oncologist).

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 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.

Treatment and study plan

IV administration of fluorine-18 fluorocholine followed by PET/CT imaging

Drug

Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.

Primary outcomes

  1. Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT

    Time frame: Concurrent with PET Procedure

    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.

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2009
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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