Recurrent Prostate Cancer
Conditions
Brief summary
The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.
Detailed description
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy. Significant advances have been made which have improved the cancer control outcomes and treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent (returning) disease usually displays rising Prostate-Specific Antigen (PSA) (a blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (i.e. recurrence in the prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence). Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET) with molecular radiotracers that are currently under study for the imaging of post-therapy recurrence. One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3-\[18F\]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with other methods in the restaging of patients with suspected recurrent prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory system including 128 subjects with prostate cancer. The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence sites will be scheduled at the subjects' convenience as soon as possible after the scans. Tissue obtained from the biopsy will undergo standard analysis to determine if prostate carcinoma cells are present. The secondary aim is to use left-over biopsy material to determine if there are genotypic differences between prostate carcinoma recurrence confined to the prostate bed and extraprostatic recurrence
Interventions
DRUGFACBC
Participants will receive a bolus of anti-\[18F\]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).
Sponsors
David M. Schuster, MD
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. Patients must be 18 years of age or older. 2. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive non-prostatectomy therapy for localized disease. 3. In the case of cryotherapy, external beam radiation, or High-Intensity Focused Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In the case of brachytherapy, treatment will have occurred at least 2 years in the past to eliminate patients with so-called PSA bump. 4. Patient will have suspicion of recurrent prostate carcinoma as defined by: the Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months 5. Ability to lie still for PET scanning 6. Patients must be able to provide written informed consent.
Exclusion criteria
1. Age less than 18. 2. Greater than T3 disease in past and/or treated with prostatectomy. 3. Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy.. 4. Does not meet above criteria of suspicious PSA elevation 5. Inability to lie still for PET scanning 6. Cannot provide written informed consent. 7. Bone scan findings characteristic for metastatic prostate carcinoma 8. Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Presence of Cancer Tissue Inside of the Prostate Bed | Up to 43 months | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease. |
| The Presence of Cancer Tissue Outside of the Prostate Bed | Up to 43 months | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FACBC Participants receiving a bolus of anti-\[18F\]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | mpMR scan was not performed | 1 |
Baseline characteristics
| Characteristic | FACBC | — |
|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 5.7 | — |
| PET-MR Interval | 7.5 days | — |
| Prior prostate cancer therapy 3+ Other Treatment Modalities | 2 Participants | — |
| Prior prostate cancer therapy Brachytherapy alone | 3 Participants | — |
| Prior prostate cancer therapy Brachytherapy as part of 3+ treatments | 5 Participants | — |
| Prior prostate cancer therapy Brachytherapy with one | 8 Participants | — |
| Prior prostate cancer therapy Cryotherapy alone | 1 Participants | — |
| Prior prostate cancer therapy Cryotherapy plus hormonal therapy | 1 Participants | — |
| Prior prostate cancer therapy Proton Therapy | 1 Participants | — |
| Prior prostate cancer therapy Radiotherapy alone | 3 Participants | — |
| Prostate-Specific Antigen (PSA) | 8.5 Nanograms per milliliter (ng/ml) STANDARD_DEVIATION 6.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 24 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
The Presence of Cancer Tissue Inside of the Prostate Bed
Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.
Time frame: Up to 43 months
Population: The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (22 out of 24 participants who received both scans). The remaining two had no biopsy or had insufficient follow-up information to reach a consensus about disease status.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | PET-CT Readers 1 and 2 | True Positivies | 13 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | PET-CT Readers 1 and 2 | False Positives | 8 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | PET-CT Readers 1 and 2 | True Negatives | 1 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | PET-CT Readers 1 and 2 | False Negatives | 0 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 1 | True Positivies | 5 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 1 | False Positives | 4 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 1 | True Negatives | 5 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 1 | False Negatives | 8 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 2 | True Positivies | 2 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 2 | False Positives | 2 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 2 | True Negatives | 7 Participants |
| FACBC | The Presence of Cancer Tissue Inside of the Prostate Bed | mpMR Reader 2 | False Negatives | 11 Participants |
Primary
The Presence of Cancer Tissue Outside of the Prostate Bed
Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5. = definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease.
Time frame: Up to 43 months
Population: The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (18 out of 24 participants who received both scans).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | PET-CT Readers 1 and 2 | True Positives | 7 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | PET-CT Readers 1 and 2 | False Positives | 1 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | PET-CT Readers 1 and 2 | True Negatives | 9 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | PET-CT Readers 1 and 2 | False Negatives | 1 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 1 | True Positives | 4 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 1 | False Positives | 3 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 1 | True Negatives | 7 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 1 | False Negatives | 4 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 2 | True Positives | 6 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 2 | False Positives | 2 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 2 | True Negatives | 8 Participants |
| FACBC | The Presence of Cancer Tissue Outside of the Prostate Bed | mpMR Reader 2 | False Negatives | 2 Participants |