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

NCT00928252 | Completed Phase 1 Results

• 2 other identifiers: RA-2008-069R21CA139687
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer; Castrate Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Metabolically Active Tumor Volume (MATV) Response

  Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT

  21 to 98 days

• Time to PSA Progression

  Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.

  2 years

• Proportional Hazards Regression Analysis of Time to PSA Progression

  PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.

  Up to 15 week post-chemotherapy

Study Arms (1)

Received 18F-fluorocholine PET/CT

EXPERIMENTAL

IV fluorine-18 labeled methylcholine before PET/CT

Drug: IV fluorine-18 labeled methylcholine before PET/CT

Interventions

IV fluorine-18 labeled methylcholine before PET/CT DRUG

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

Also known as: 18F-fluorocholine PET/CT

Received 18F-fluorocholine PET/CT

Eligibility Criteria

• Age: 18 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
• 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.
• A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal.
• 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.

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 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.

Sponsors & Collaborators

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

Results Point of Contact

• Title: Sandi Kwee, MD, PhD
• Organization: The Queen's Medical Center

skwee@queens.org

8086915466

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: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 14, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-07

Locations

US (1)