Prostate Adenocarcinoma
Conditions
Brief summary
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
Detailed description
PRIMARY OBJECTIVES I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation. II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine \[18F\]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making. III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes. ARM II: Patients receive 68Ga-PSMA IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes. After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
DRUGFluciclovine F18
Given IV
RADIATIONGallium Ga68-labeled PSMA-11
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
Emory University
Telix Pharmaceuticals (Innovations) Pty Limited
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the prostate, post radical-prostatectomy * Detectable prostate-specific antigen (PSA) * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2 * No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan * No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis * Willingness to undergo pelvic radiotherapy
Exclusion criteria
* Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy) * Inability to undergo fluciclovine or Ga-PSMA PET-CT * Definitive findings of systemic metastasis on conventional imaging or biopsy * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Severe acute co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Disease-Free at 2 Years | Up to 2 years after study start | A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision to Offer Radiotherapy | Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks | Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test. |
| Decision to Treat Pelvic Nodes | Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks | Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test. |
| Decision to Boost Between the Initial and Final Treatment Decisions | Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks | Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test. |
| Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV) | Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks | Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography \[PET\]) and final (post-PET) radiation treatment plans. |
| Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40)) | Up to 4 weeks post-treatment | Spearman's correlation coefficient will be used to measure the correlations of the Rectum dosimetric endpoints (Rectum 65 and Rectum V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. |
| Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40)) | Up to 4 weeks post-treatment. | Spearman's correlation coefficient will be used to measure the correlations of the Bladder dosimetric endpoints (Bladder V65 and Bladder V40) with the grades (0, 1, 2, or 3) (as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) with acute genitourinary (GU) toxicity. A Wald test will be used to test the significance level of their correlations. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshesh Jani, MD, MSEE
Emory University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants |
| Age, Continuous | 62 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 70 | 0 / 70 |
| other Total, other adverse events | 46 / 70 | 47 / 70 |
| serious Total, serious adverse events | 2 / 70 | 1 / 70 |
Outcome results
None listed