Prostate Cancer Clinical Trial

Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT03762759

Recruitment Status:

Recruiting

Sponsor:

Emory University

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There are 3 Locations for this study

See Locations Near You

Grady Health System
Atlanta Georgia, 30303, United States More Info
Larcee Cutright
Contact
404-616-6353
[email protected]
Bridget Fielder, RN, MSN
Contact
404-778-5625
[email protected]
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Bridget Fielder, RN, MSN
Contact
404-778-5625
[email protected]
Giesla Rodgers
Contact
404-778-5162
[email protected]
Emory Saint Joseph's Hospital
Atlanta Georgia, 30342, United States More Info
Alicia Escobar
Contact
678-843-7029
[email protected]
Pam Bourbo, RN, MPH
Contact
678-843-6875
pam[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT03762759

Recruitment Status:

Recruiting

Sponsor:


Emory University

How clear is this clinincal trial information?

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