Measurement of Anti-Androgen Response Using 18F-choline PET/CT in Androgen-Insensitive Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT00928174
First received: June 24, 2009
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether PET/CT using 18F-choline 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 methylcholine 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 18F-choline 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:
  • PSA Outcome [ Time Frame: 30-75 day follow-up ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: IV administration of fluorine-18 methylcholine followed by PET/CT imaging
    Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928174

Locations
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Queen's Medical Centre
Investigators
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
ClinicalTrials.gov Identifier: NCT00928174     History of Changes
Other Study ID Numbers: RA-2009-009, R21CA139687
Study First Received: June 24, 2009
Last Updated: July 31, 2013
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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Androgens
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones

ClinicalTrials.gov processed this record on April 17, 2014