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

NCT ID: NCT00928174

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Arm

Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Queen's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sandi Kwee

Sandi A. Kwee, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandi A Kwee, MD

Role: PRINCIPAL_INVESTIGATOR

The Queen's Medical Center

Locations

The Queen's Medical Center

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26912444 (View on PubMed)

Other Identifiers

R21CA139687

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RA-2009-009

Identifier Type: -

Identifier Source: org_study_id