Prostate Cancer
Conditions
Brief summary
This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
Interventions
Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
Sponsors
American College of Radiology
IND 2 Results LLC
Syne Qua Non Limited
Blue Earth Diagnostics
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
* History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy). * Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as : * Post prostatectomy: Detectable or rising PSA level that is \>0.2 ng/mL with a second confirmatory level of \>0.2 ng/mL * Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir * Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis). * Being considered for salvage therapy * Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past. * Previous brachytherapy treatment will have occurred at least 2 years in the past * Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist) * Androgen deprivation therapy (ADT) in the past 3 months * History of bilateral orchidectomy * Inability to tolerate 18F-fluciclovine PET/CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | 2-22 days post PET CT | The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | 6 months | The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up. Investigators were instructed to assess any clinically significant change from the revised management plan. |
| The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population | 1 week | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT |
| The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population | 1 week | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally |
| The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | 6 months | Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI |
| The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | 6 months | Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI |
Countries
United States
Participant flow
Recruitment details
The study was conducted between 01 June 2016 (first patient, screening visit) and 01 November 2017 (last patient, last contact) at 17 sites in the USA. Overall 17 sites were initiated, of which 15 sites enrolled patients.
Participants by arm
| Arm | Count |
|---|---|
| 18F-fluciclovine PET CT Single intravenous administration of 18F-fluciclovine PET/CT. | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal prior to 18F-fluciclovine PET | 8 |
Baseline characteristics
| Characteristic | 18F-fluciclovine PET CT |
|---|---|
| Age, Continuous | 67.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 188 Participants |
| Region of Enrollment United States | 213 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 213 |
| other Total, other adverse events | 44 / 213 |
| serious Total, serious adverse events | 0 / 213 |
Outcome results
Primary
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Time frame: 2-22 days post PET CT
Population: For the primary analysis population, of the 213 patients included in the EAS, 122 patients with a positive 18F-fluciclovine scan and 91 patients with a negative 18F-fluciclovine scan had a pre 18F-fluciclovine PET/CT treatment management plan.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Overall Evaluable Analysis Set | Patients with Revised Management Plan | 126 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Overall Evaluable Analysis Set | No Revision to Management Plan | 87 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Positive 18F-fluciclovine Scan | Patients with Revised Management Plan | 88 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Positive 18F-fluciclovine Scan | No Revision to Management Plan | 34 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Negative 18F-fluciclovine Scan | Patients with Revised Management Plan | 38 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | Negative 18F-fluciclovine Scan | No Revision to Management Plan | 53 Participants |
Secondary
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up. Investigators were instructed to assess any clinically significant change from the revised management plan.
Time frame: 6 months
Population: 211 participants completed the study (actual treatment assessed at study completion).~Results also presented by 18F-fluciclovine PET CT results.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Overall | Change from the revised management plan | 80 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Overall | No change from the revised management plan | 131 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Positive 18F fluciclovine Scan | Change from the revised management plan | 47 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Positive 18F fluciclovine Scan | No change from the revised management plan | 74 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Negative 18F fluciclovine Scan | Change from the revised management plan | 33 Participants |
| 18F-fluciclovine PET CT | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | Negative 18F fluciclovine Scan | No change from the revised management plan | 57 Participants |
Secondary
The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time frame: 6 months
Population: Only scans graded as positive or negative by the adjudication panel were included in these calculations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-fluciclovine PET CT | The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | 100 Percentage of scans |
Secondary
The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time frame: 6 months
Population: Only scans graded as positive or negative by the adjudication panel were included in these calculations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-fluciclovine PET CT | The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | 100 Percentage of scans |
Secondary
The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
Time frame: 1 week
Population: Results presented for Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 18F-fluciclovine PET CT | The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population | 122 Participants |
Secondary
The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
Time frame: 1 week
Population: Participants may have lesions detected in both regions (prostate/prostate bed and extra-prostatic).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-fluciclovine PET CT | The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population | Prostate or Prostate Bed | 64 Participants |
| 18F-fluciclovine PET CT | The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population | Extra-prostatic | 80 Participants |