Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Emory University
- Enrollment
- 140
- Locations
- 3
- Primary Endpoint
- Percentage of Participants Disease-Free at 2 Years
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Computed Tomography (Procedure)
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Positron Emission Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Computed Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Positron Emission Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Gallium Ga68-labeled PSMA-11 (Radiation)
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Intervention: Fluciclovine F18 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Disease-Free at 2 Years
Time Frame: 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 Outcomes
- Decision to Offer Radiotherapy(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Decision to Treat Pelvic Nodes(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Decision to Boost Between the Initial and Final Treatment Decisions(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- 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)
- 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)
- 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.)
Investigators
Ashesh B Jani
Principal Investigator
Emory University