Description:
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.
Title
- Brief Title: Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
- Official Title: Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
Clinical Trial IDs
- ORG STUDY ID:
IRB00106863
- SECONDARY ID:
NCI-2018-02702
- SECONDARY ID:
RAD4516-18
- SECONDARY ID:
R01CA226992
- NCT ID:
NCT03762759
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Fluciclovine F18 | anti-3-[18F]FACBC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, FACBC, [18F]FACBC, Axumin | Arm I (fluciclovine F18, PET/CT) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm I (fluciclovine F18, PET/CT) | Experimental | Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. | |
Arm II (68Ga-PSMA, PET/CT) | Active Comparator | Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease-free survival |
Time Frame: | Up to 2 years after study start |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Decision to offer radiotherapy |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | 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. |
Measure: | Decision to treat pelvic nodes |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | 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. |
Measure: | Decision to boost between the initial and final treatment decisions |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | 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. |
Measure: | Prostate bed clinical target volume (CTV) and planning target volume (PTV) |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | 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. |
Measure: | PTV of the rectum (V65, V40) |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute genitourinary (GU) or gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively. |
Measure: | PTV of the bladder (V65, V40) |
Time Frame: | Up to 5 years after study start |
Safety Issue: | |
Description: | Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute GU or GI toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Emory University |
Last Updated
August 9, 2021