Prostate Cancer
Conditions
Keywords
Androgen insensitive prostate cancer
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.
Interventions
DRUGIV 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.
Sponsors
National Institutes of Health (NIH)
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 120 Years
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | Concurrent with PET Procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Customized <40 | 0 participants |
| Age, Customized 40-49 years | 0 participants |
| Age, Customized 50-59 years | 1 participants |
| Age, Customized 60-69 years | 9 participants |
| Age, Customized 70-79 years | 4 participants |
| Age, Customized 80-89 years | 13 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
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.
Time frame: Concurrent with PET Procedure
Population: Outcome Measure Data Table reflects data from the 22 subjects completing the current study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | PSA > 4 ng/mL (19 cases) | 100 %PET-positive cases in a given PSA range |
| Single Arm | Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | PSA 2-4 ng/mL (2 cases) | 100 %PET-positive cases in a given PSA range |
| Single Arm | Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | PSA > 0.5 - 2 ng/mL (1 cases) | 100 %PET-positive cases in a given PSA range |
| Single Arm | Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | PSA <= 0.5 ng/mL (0 cases) | 0 %PET-positive cases in a given PSA range |