Hormone Refractory Prostate Cancer
Conditions
Keywords
Hormone Refractory Prostate Cancer, Castrate Resistant Prostate Cancer
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.
Interventions
DRUGIV fluorine-18 labeled methylcholine before PET/CT
Intervention at pre-treatment, and at two timepoints post treatment intiation.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Queen's Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolically Active Tumor Volume (MATV) Response | 21 to 98 days | Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT |
| Time to PSA Progression | 2 years | Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%. |
| Proportional Hazards Regression Analysis of Time to PSA Progression | Up to 15 week post-chemotherapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm 18F-fluoromethylcholine IV in conjunction with PET/CT imaging
IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 73 Years |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 5 / 45 |
Outcome results
Primary
Metabolically Active Tumor Volume (MATV) Response
Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
Time frame: 21 to 98 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Received 18F-fluorocholine PET/CT | Metabolically Active Tumor Volume (MATV) Response | 20 Participants |
Primary
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.
Time frame: Up to 15 week post-chemotherapy
Population: Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Received 18F-fluorocholine PET/CT | Proportional Hazards Regression Analysis of Time to PSA Progression | 0.246 Hazard Ratio |
Primary
Time to PSA Progression
Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received 18F-fluorocholine PET/CT | Time to PSA Progression | MATV reduction > or = 30% | 194 days | Standard Error 13.759 |
| Received 18F-fluorocholine PET/CT | Time to PSA Progression | MATV reduction < 30% | 116 days | Standard Error 26.929 |