ARTO trial (NCT03449719), a randomized phase II trial enrolling oligometastatic castration-resistant prostate cancer patients treated with first-line abiraterone acetate with or without stereotactic body radiation therapy: Preliminary results comprehensive of biochemical outcomes and circulating tumor cells analysis.

Authors

null

Giulio Francolini

University of Florence, Florence, Italy

Giulio Francolini , Pietro Garlatti , Mauro Loi , Beatrice Detti , Michele Aquilano , Andrea Allegra , Barbara Guerrieri , Viola Salvestrini , Pamela Pinzani , Chiara Bellini , Francesca Salvianti , Giulia Stocchi , Lucia Pia Ciccone , Giulia Salvatore , Mariangela Sottili , Vanessa Di Cataldo , Isacco Desideri , Monica Mangoni , Icro Meattini , Lorenzo Livi

Organizations

University of Florence, Florence, Italy, Radiotherapy Department, University of Florence, Florence, Italy, AOU Careggi, Firenze, Italy, Radiotherapy Unit, A.O.U. Careggi, Florence, Italy, University of Florence, Firenze, Italy, Radiotherapy Department, University of Florence, Firenze, Italy, Clinical Biochemistry and Clinical Molecular Biology Unit, Department of Experimental and Clinical Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy, Radiotherapy Department, Università di Firenze, Firenze, Italy, Radiotherapy Department, Florence, Italy, Department of a  Biomedical, Experimental and Clinical Sciences "Mario Serio", Section of Radiation Oncology, University of Florence, Florence, Italy, Cyberknife Center, Istituto Fiorentino di Cura e Assistenza (IFCA), Firenze, Italy, Radiation Oncology Unit-Oncology Department, University of Florence, Florence, Italy

Research Funding

No funding received
None

Background: Androgen Receptor Targeted Agents (ARTA) represent one of the main treatment options for metastatic castrate resistant prostate cancer (mCRPC). Addition of stereotactic radiation therapy (SBRT) to ablate metastatic foci may improve clinical outcomes in oligometastatic setting. ARTO trial (NCT03449719) is a randomized phase II trial testing the benefit of upfront SBRT on all sites of metastatic disease in oligo-mCRPC patients undergoing I line therapy with Abiraterone Acetate (AA). In this preliminary analysis, we report results after 6 months of follow up, together with an exploratory analysis of androgen receptor splice variants (ARV7/ARFL) Prostate Specific Antigen (PSA) and Prostate Specific Membrane Antigen (PSMA) expression on Circulating Tumor Cells (CTCs) detected in this cohort of patients. Methods: 31 patients affected by oligo-mCRPC (defined as < 3 non-visceral metastatic lesions) were randomized to receive I line AA therapy with or without SBRT on all metastatic sites. Baseline blood samples to detect CTCs and evaluate their ARV7, ARFL, PSA and PSMA expression were taken before AA treatment start. Assessments comprehensive of clinical examination and serum PSA were performed every three months. Toxicity was assessed by the Common Terminology Criteria for Adverse Events toxicity scale (CTCAE v.4.03). Results: Thirteen and 18 patients were enrolled in the treatment and control arm, respectively. Nineteen metastatic lesions were treated with SBRT in the treatment arm. At 6 months, complete response (defined as a serum PSA level < 0.2 ng/dl) and biochemical response (defined as a PSA reduction > 50% if compared to baseline) were achieved in 6 vs 4 and in 10 vs 8 patients in the treatment vs control arm, respectively. One patient in the treatment arm died for other causes, 1 biochemical progression occurred in the control arm. No adverse events occurred in both arms of treatment. CTCs analysis was available for 10 patients, out of whom 4 were found positive for CTCs (1 and 3 from the treatment and control arm, respectively). ARV7 and ARFL were expressed in 1 patient from the control arm, PSMA was expressed in all CTC positive patients, PSA was expressed in 2 patients from the control and one from the treatment arm. Conclusions: SBRT+AA in oligo-mCRPC patients was safe and yielded promising biochemical results. CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients. Data about ARV7, ARFL, PSA and PSMA expression represent an interesting snapshot of biomarker arrangement in this setting. Clinical trial information: NCT03449719

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Abstract Details

Meeting

2021 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Prostate Cancer - Advanced Disease

Track

Prostate Cancer - Advanced

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT03449719

Citation

J Clin Oncol 39, 2021 (suppl 6; abstr 118)

DOI

10.1200/JCO.2021.39.6_suppl.118

Abstract #

118

Poster Bd #

Online Only

Abstract Disclosures