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Phase 2 N=27 Diagnostic

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

Prostate Cancer

Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT — 100; 100; 100; 0 %PET-positive cases in a given PSA range

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
IV administration of fluorine-18 fluorocholine followed by PET/CT imaging (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Queen's Medical Center
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
100; 100; 100; 0

Summary

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.

Eligibility Criteria

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 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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00928174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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