ASCO 2020: Initial Experience of the Adjuvant Treatments to the Local Tumor for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms, a Multicenter, Phase II Randomized Controlled Trial (IP2-ATLANTA)
In this Poster Session at the 2020 American Society of Clinical Oncology Virtual Annual Meeting, Martin John Connor, MBBS, MRCS, and colleagues presented the design of the IP2-ATLANTA trial.
This is a phase II, multicentre, three-arm randomized controlled trial using a positive comparator arm. Men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer (mCSPC), within three months of commencing androgen deprivation therapy and with a performance status of 0-2 are eligible for inclusion. Patients receive a CT of the chest, abdomen, and pelvis, multiparametric MRI, and prostate biopsy before inclusion.
Following enrollment, patients are randomized in a 1:1:1 fashion to a standard of care systemic therapy, Intervention 1 (Minimally invasive ablative therapy to the prostate +/- pelvic lymph node dissection [PLND]) in addition to systemic therapy, OR Intervention 2 (prostate radiotherapy +/- lymph nodes OR Radical prostatectomy +/- PLND) in addition to systemic therapy. Standard of care systemic therapy includes ADT, docetaxel, or androgen-axis inhibitors.
Patients with a low burden of metastatic disease, according to CHAARTED criteria, are eligible for metastasis-directed therapy (including either stereotactic ablative radiotherapy [SABR] or surgery) if randomized to Intervention 1 or 2, as clinically indicated.
Follow-up will continue for a minimum of 2 years and a maximum of 4 years to assess the primary outcome of progression-free survival (PFS). Key secondary outcomes include overall survival; urinary, sexual & rectal side-effects; patient-reported outcome measures; and adverse events.
While a total accrual of 918 patients is planned, this is preceded by an initial internal pilot feasibility phase (n=80). To date, 42 men in this feasibility phase have been recruited. The median recruitment rate is 85%.
Presented by: Martin John Connor, MBBS, MRCS, Clinical Research Fellow, Faculty of Medicine, Department of Surgery & Cancer, Imperial College London.
Co-Authors: Taimur T Shah, Johanna Sukumar, Olivia Frances Naismith, Emily Day, Francesca Fiorentino, Alison Falconer, Naveed Sarwar, Michael Gonzalez, Shiva Gayadeen, Kamalram Thippu Jayaprakash, John McGrath, Gail Horan, Catherine Heath, Stephen Mangar, Vincent Khoo, Tim Dudderidge, John Nicholas Staffurth, Mathias Winkler, Hashim Uddin Ahmed
Written by: Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center Contact: @WallisCJD on Twitter at the 2020 ASCO Annual Meeting, Virtual Scientific Program #ASCO20, May 29-31, 2020.