Aurélie De Bruycker1, Phuoc T Tran2, Ariel H Achtman3, Piet Ost4. 1. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium. aurelie.debruycker@ugent.be. 2. Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine Hospital, Baltimore, USA. 3. The Movember Foundation, Melbourne, Australia. 4. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent University, C. Heymanslaan 10, 9000, Ghent, Belgium.
Abstract
PURPOSE: Thanks to the introduction of more sensitive/specific imaging and minimally invasive treatment techniques, the oligometastatic state in prostate cancer (PCa) has attracted the interest of the uro-oncological community. We aim to identify and analyze trials across five registries to gain insights into the directions this field is moving. METHODS: A systematic review of trials on oligometastatic PCa registered on ClinicalTrials.gov, ANZCTR, ISRCTN, Netherlands and UMIN Clinical Trials Registries was performed using the following keywords: 'prostate cancer' and 'oligo'. Data were extracted from ongoing/completed trials, with an unreported primary endpoint in a peer-reviewed journal, as of May until August, 2018. RESULTS: We identified 41 trials on oligometastatic PCa. Twenty-four trials are conducted in North America and 14 in Europe. Up to 70% are phase I or II trials and < 10% (n = 4) are in phase III. Less than 50% (n = 17) are randomized controlled trials. Oligometastases are PET detected in 25 trials. Studies on synchronous oligometastatic (n = 12; 29%) or oligorecurrent (n = 14; 34%) PCa are equally represented, the remainder focus on mixed states (n = 15; 37%). The majority (n = 39; 95%) of trials investigate local treatment options (RP: 5; RT: 9; RP ± RT: 7; metastasis-directed therapy: 28) with (72%) or without (28%) systemic treatment. The remaining two are imaging studies. Progression-free (PFS; 17/41; 41%) or overall survival (OS; 3/41; 7%) is defined as primary endpoint in half of all trials, others are 'safety/toxicity' or 'PSA response'. CONCLUSIONS: With 41 ongoing trials, there is great interest in oligometastatic PCa. Most trials address local ablative treatments both for prostate and/or metastases, typically by radiotherapy, and several attempts to determine the benefit of adding systemic therapy. The field will hopefully have definitive answers after completion of four ongoing phase III trials.
PURPOSE: Thanks to the introduction of more sensitive/specific imaging and minimally invasive treatment techniques, the oligometastatic state in prostate cancer (PCa) has attracted the interest of the uro-oncological community. We aim to identify and analyze trials across five registries to gain insights into the directions this field is moving. METHODS: A systematic review of trials on oligometastatic PCa registered on ClinicalTrials.gov, ANZCTR, ISRCTN, Netherlands and UMIN Clinical Trials Registries was performed using the following keywords: 'prostate cancer' and 'oligo'. Data were extracted from ongoing/completed trials, with an unreported primary endpoint in a peer-reviewed journal, as of May until August, 2018. RESULTS: We identified 41 trials on oligometastatic PCa. Twenty-four trials are conducted in North America and 14 in Europe. Up to 70% are phase I or II trials and < 10% (n = 4) are in phase III. Less than 50% (n = 17) are randomized controlled trials. Oligometastases are PET detected in 25 trials. Studies on synchronous oligometastatic (n = 12; 29%) or oligorecurrent (n = 14; 34%) PCa are equally represented, the remainder focus on mixed states (n = 15; 37%). The majority (n = 39; 95%) of trials investigate local treatment options (RP: 5; RT: 9; RP ± RT: 7; metastasis-directed therapy: 28) with (72%) or without (28%) systemic treatment. The remaining two are imaging studies. Progression-free (PFS; 17/41; 41%) or overall survival (OS; 3/41; 7%) is defined as primary endpoint in half of all trials, others are 'safety/toxicity' or 'PSA response'. CONCLUSIONS: With 41 ongoing trials, there is great interest in oligometastatic PCa. Most trials address local ablative treatments both for prostate and/or metastases, typically by radiotherapy, and several attempts to determine the benefit of adding systemic therapy. The field will hopefully have definitive answers after completion of four ongoing phase III trials.
Entities:
Keywords:
Clinical trials; Neoplasm; Oligometastases; Oligorecurrence; PET-CT; Prostate cancer
Authors: Martin J Connor; Taimur T Shah; Gail Horan; Charlotte L Bevan; Mathias Winkler; Hashim U Ahmed Journal: Nat Rev Clin Oncol Date: 2019-11-11 Impact factor: 66.675
Authors: Sun Hyun Bae; Won Il Jang; Hyun-Cheol Kang; Young Il Kim; Yong Ho Kim; Woo Chul Kim; Hee Kwan Lee; Jin Ho Kim Journal: Ann Transl Med Date: 2021-08
Authors: Martin J Connor; Mesfin G Genie; David Burns; Edward J Bass; Michael Gonzalez; Naveed Sarwar; Alison Falconer; Stephen Mangar; Tim Dudderidge; Vincent Khoo; Mathias Winkler; Hashim U Ahmed; Verity Watson Journal: Eur Urol Open Sci Date: 2021-12-20
Authors: Martin John Connor; Mesfin G Genie; Michael Gonzalez; Naveed Sarwar; Kamalram Thippu Jayaprakash; Gail Horan; Feargus Hosking-Jervis; Natalia Klimowska-Nassar; Johanna Sukumar; Tzveta Pokrovska; Dolan Basak; Angus Robinson; Mark Beresford; Bhavan Rai; Stephen Mangar; Vincent Khoo; Tim Dudderidge; Alison Falconer; Mathias Winkler; Verity Watson; Hashim Uddin Ahmed Journal: BMJ Open Date: 2021-11-18 Impact factor: 2.692
Authors: Simon Kirste; Stephanie G C Kroeze; Christoph Henkenberens; Nina-Sophie Schmidt-Hegemann; Marco M E Vogel; Jessica Becker; Constantinos Zamboglou; Irene Burger; Thorsten Derlin; Peter Bartenstein; Juri Ruf; Christian la Fougère; Matthias Eiber; Hans Christiansen; Stephanie E Combs; Arndt-Christian Müller; Claus Belka; Matthias Guckenberger; Anca-Ligia Grosu Journal: Front Oncol Date: 2021-05-10 Impact factor: 6.244