1016 - Hypofractionated Radiotherapy for Prostate Cancer: Preliminary Results from the HypoAfrica Study

A. O. Joseph¹, A. Mallum², S. Kibudde³, T. A. Ngoma⁴, A. Ajose⁵, E. Lugina⁶, J. Dachi Kisukari⁶, S. Adeneye⁷, T. Mkhize⁸, A. Alabi⁵, I. El Hamamsi⁷, M. A. Mseti⁶, P. Akowe⁷, A. Studen⁹, H. Li¹⁰, J. Lehmann¹¹, M. S. S. Huq¹², S. M. Avery¹³, W. Ngwa¹⁴, and L. Incrocci¹⁵; ¹NSIA-LUTH Cancer Centre, Lagos, Nigeria, Lagos, Nigeria, ²Department of Radiotherapy and Oncology, College of Health Sciences University of KwaZulu Natal, Durban, South Africa, ³Makerere University, Kampala, Uganda, ⁴Ocean Road Cancer Institute, Dar Es Salaam, Tanzania, United Republic of, ⁵Lagos University Teaching Hospital, Lagos, Nigeria, ⁶Ocean Road Cancer Institute, Dar Es Salam, Tanzania, United Republic of, ⁷NSIA-LUTH Cancer Center, Lagos, Nigeria, ⁸Inkosi Albert Luthuli Central Hospital, Durban, South Africa, ⁹University of Ljubljana, Ljubljana, Slovenia, ¹⁰Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, ¹¹Calvary Mater Newcastle, Newcastle, Australia, ¹²Department of Radiation Oncology, UPMC Hillman Cancer Center, Pittsburgh, PA, ¹³University of Pennsylvania, Philadelphia, PA, ¹⁴John Hopkins University Hospital, Baltimore, MD, ¹⁵Department of Radiotherapy, Erasmus Medical Center, Rotterdam, Netherlands

Purpose/Objective(s): Prostate cancer (PCa) is the most common cancer among men in most African countries. The rising number of PCa patients in sub-Saharan Africa, especially in the context of resource limitations, warrants the adoption of evidence-based approaches that enhance treatment accessibility. Hypofractionated radiotherapy (HFRT) substantially increases access to radiotherapy by reducing overall treatment cost and duration for patients, while also reducing the burden on limited personnel and infrastructural resources. Several randomized studies conducted in Europe and the USA have demonstrated that HFRT for PCa is non-inferior to conventional radiotherapy in terms of toxicity and treatment outcomes. This study aims to explore the feasibility of applying moderate HFRT for the treatment of localized PCa in an African setting. Materials/

Methods: HypoAfrica is a multi-center, prospective, non-randomized, phase 2 non-inferiority trial that recruited men with histologically confirmed localized PCa. Patients received an HFRT total dose of either 60Gy (low- and intermediate-risk PCa) or 62Gy (high-risk PCa) delivered in 20 fractions using IMRT or VMAT, with neo-adjuvant concurrent and adjuvant androgen deprivation therapy. The primary endpoint was gastrointestinal (GI) and genitourinary (GU) toxicities assessed using CTCAE criteria before the start and upon completion of radiotherapy and at 3-, 12-, and 24-months post completion of radiotherapy.
Results: Between 2021 and 2023, 182 men were enrolled from three centers in Nigeria, South Africa, and Tanzania. Safety data is reported for 133 men who have completed HFRT. The median age of these participants is 72 years (range 51-82 years). A total of 102 men have completed their 3-month post-radiotherapy assessment and 24 have completed their 12-month post-radiotherapy assessment. Fifty-two percent received 60Gy (n=69) and 48% (n=64) received 62Gy. Radiotherapy was administered either via IMRT (n=82, 62%) or VMAT (n=51, 38%) treatments. At completion of radiotherapy, =2 grade toxicity was reported by 3% (n=4) of participants for GI and 5% (n=6) for GU, whereas at three months following completion of radiotherapy, =2 grade toxicity was reported by none and 2% (n=2) of participants for GI and GU, respectively. Twelve months post-radiotherapy, =2 grade toxicity was reported by 4% (n=1) and 8% (n=2) of participants for GI and GU, respectively.
Conclusion: These data demonstrate that HFRT for localized PCa is feasible in Africa with results in acute GI and GU toxicities being similar and even lower to those seen in HFRT trials from Europe (=2 grade toxicity in 38% and 49% [4 weeks after HFRT start] and 3% and 5% [18 weeks after HFRT start] of participants for GI and GU, respectively). Patients will continue to be monitored to evaluate treatment outcomes and late toxicities for up to two years. Future plans include validating these findings at additional facilities in Africa.