Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer

NCT ID: NCT00928252

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.

Detailed Description

Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.

Conditions

Hormone Refractory Prostate Cancer

Study Design

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

Study Groups

Received 18F-fluorocholine PET/CT

IV fluorine-18 labeled methylcholine before PET/CT

Group Type: EXPERIMENTAL

IV fluorine-18 labeled methylcholine before PET/CT

Intervention Type: DRUG

Intervention at pre-treatment, and at two timepoints post treatment intiation.

Interventions

IV fluorine-18 labeled methylcholine before PET/CT

Intervention at pre-treatment, and at two timepoints post treatment intiation.

Intervention Type: DRUG

Other Intervention Names

18F-fluorocholine PET/CT

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. Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA > 5.0 ng/ml.

5. A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.

6. Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T.

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 or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.

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

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

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-2008-069

Identifier Type: -

Identifier Source: org_study_id