Status:
ACTIVE_NOT_RECRUITING
Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Lead Sponsor:
Emory University
Collaborating Sponsors:
Telix Pharmaceuticals (Innovations) Pty Limited
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 tr...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03762759
Start Date
May 10 2019
End Date
December 31 2025
Last Update
May 17 2024
Active Locations (3)
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1
Grady Health System
Atlanta, Georgia, United States, 30303
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342