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

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Primary Purpose

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Fluciclovine F18

Gallium Ga68-labeled PSMA-11

Positron Emission Tomography

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Grady Health System
Emory University Hospital/Winship Cancer Institute
Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (fluciclovine F18, PET/CT)

Arm II (68Ga-PSMA, PET/CT)

Arm Description

Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Outcomes

Primary Outcome Measures

Disease-free survival

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

Decision to offer radiotherapy

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

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

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 clinical target volume (CTV) and planning target volume (PTV)

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.

PTV of the rectum (V65, V40)

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.

PTV of the bladder (V65, V40)

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.

Full Information

NCT ID

NCT03762759

First Posted

November 27, 2018

Last Updated

May 4, 2023

Sponsor

Emory University

Collaborators

Telix International Pty Ltd, National Cancer Institute (NCI), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03762759

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Telix International Pty Ltd, National Cancer Institute (NCI), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (fluciclovine F18, PET/CT)

Arm Type

Experimental

Arm Description

Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Arm Title

Arm II (68Ga-PSMA, PET/CT)

Arm Type

Active Comparator

Arm Description

Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CT, CT scan, Computerized axial tomography, CAT, CAT scan

Intervention Description

Undergo PET/CT

Intervention Type

Drug

Intervention Name(s)

Fluciclovine F18

Other Intervention Name(s)

anti-3-[18F]FACBC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, FACBC, [18F]FACBC, Axumin

Intervention Description

Given IV

Intervention Type

Radiation

Intervention Name(s)

Gallium Ga68-labeled PSMA-11

Other Intervention Name(s)

68Ga-PSMA, 68Ga PSMA, [68Ga] Prostate-specific Membrane Antigen 11, 68Ga-DKFZ-PSMA-11, 68Ga-PSMA-HBED-CC

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

PET, PET scan, Proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo PET/CT

Primary Outcome Measure Information:

Title

Disease-free survival

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.

Time Frame

Up to 2 years after study start

Secondary Outcome Measure Information:

Title

Decision to offer radiotherapy

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.

Time Frame