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

NCT00928174 | Completed Phase 1 Results

• 2 other identifiers: RA-2009-009R21CA139687
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Androgen insensitive prostate cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Concurrent with PET Procedure

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

• Lee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16.

  PMID: 26912444 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Sandi Kwee, Principal Investigator
• Organization: The Queen's Medical Center

skwee@queens.org

808-691-5466

Study Officials

• Sandi A Kwee, MD

  The Queen's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sandi A. Kwee, M.D.

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 11, 2015
• Results First Posted: November 19, 2014

Record last verified: 2015-10

Locations

US (1)