18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Abiraterone Acetate
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|ClinicalTrials.gov Identifier: NCT04158245|
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer||Drug: 18F-fluciclovine PET Scan||Phase 2|
Prostate cancer is a hormonally-driven disease and androgens are key in the growth of both normal prostate and prostate cancer cells. Once mCRPC is evident, most patients receive a second-generation hormonal therapy to further suppress the synthesis or androgens (abiraterone) and to block androgen receptor (AR) activation, nuclear translocation and DNA binding (enzalutamide).
Conventional imaging of prostate cancer has limitations in staging, restaging after biochemical relapse, and response assessment. Functional imaging with positron emission tomography (PET) can target various aspects of tumor biology and is clearly superior in the detection of extra-prostatic disease. 18F-fluciclovine is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters that are upregulated in prostate cancer cells.
18F-fluciclovine is approved for PET imaging to identify sites of prostate cancer recurrence in men with rising prostate specific antigen (PSA) following prior definitive treatment. This study describes the changes in 18F-fluciclovine PET scan and compare these results with PSA and conventional computerized tomography (CT) and bone scans, in mCRPC patients treated with abiraterone acetate-prednisone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate.|
|Masking:||None (Open Label)|
|Official Title:||Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With Abiraterone Acetate: A Pilot Study|
|Actual Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: 18F-fluciclovine PET Scan
Single intravenous administration of 18F-fluciclovine for PET Scan.
Drug: 18F-fluciclovine PET Scan
The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
Other Name: Axumin
- Changes in 18F-fluciclovine PET scan for patients with mCRPC on treatment with abiraterone-prednisone [ Time Frame: 12 weeks ]To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with abiraterone-prednisone, and at 12 weeks after abiraterone therapy initiation.
- PET scan vs. conventional CT and bone scan [ Time Frame: 12 weeks ]A comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with abiraterone-prednisone, and at 12 weeks after starting abiraterone; and to correlate these changes with PSA response and progression after starting abiraterone.
- Compare the PET scan results with the genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA) [ Time Frame: 12 weeks ]To understand disease heterogeneity and possible heterogenous progression and change in patient management as well as to compare the 18F-fluciclovine PET findings with genomic alterations found in ctDNA especially in the androgen receptor (AR) gene, using an NGS assay of patients with mCRPC treated with abiraterone
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158245
|Contact: Pedro C. Barata, MD, MSc||(504) firstname.lastname@example.org|
|United States, Louisiana|
|Tulane Cancer Center Clinic||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Patrick Cotogno 504-988-6542 email@example.com|
|Principal Investigator: Pedro Barata, MD|
|Principal Investigator:||Pedro C. Barata, MD, MSc||Tulane University School of Medicine|