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An Intraprostatic Modified Release Formulation of Antiandrogen 2-Hydroxyflutamide for Localized Prostate Cancer
Tampere Univ Hosp, Dept Urol, Tampere, Finland.; Univ Tampere, Tampere, Finland.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
Helsinki Univ Hosp, Helsinki, Finland.
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2017 (English)In: Journal of Urology, ISSN 0022-5347, E-ISSN 1527-3792, Vol. 198, no 6, p. 1333-1339Article in journal (Refereed) Published
Abstract [en]

PURPOSE: To investigate tolerability, safety and antitumor effects of a novel intra-prostatic depot formulation of antiandrogen 2-hydroxyflutamide (2-HOF in NanoZolid(®)) in men with localized prostate cancer (PCa).

MATERIALS AND METHODS: Two clinical trials, LPC-002 and LPC-003, were conducted on a total of 47 men. The formulation was injected transrectally into the prostate with ultrasound guidance. In LPC-002 the effects on prostate specific antigen (PSA) and prostate volume (PV) were measured over 6 months on 24 patients. In LPC-003, antitumor effects were evaluated with histopathology, magnetic resonance imaging (MRI) including spectroscopy (MRS) during 6 or 8 weeks on 23 patients. In both studies, testosterone and 2-HOF in plasma were measured, as well as quality-of-life parameters.

RESULTS: In LPC-002 (mean dose 690 mg) a reduction in PSA and PV was observed. The nadir values for PSA and PV were on average 24.9 % and 14.0 % below baseline, respectively. When increasing the dose in LPC-003 (920 mg and 1740 mg), the average PSA dropped 16 % and 23 %, respectively, after 6 and 8 weeks. MRI/MRS showed morphological changes and a global drop in metabolite concentrations following treatment indicating an antitumor response. The injections did not result in hormone related side effects. In total, three serious adverse events were reported, all resolved by oral antibiotic treatment.

CONCLUSIONS: The intraprostatic injections of 2-HOF depot formulations indicated anti-tumor effects and proved safe and tolerable. However, for better anti-cancer effects higher doses and better dose distribution are suggested.

Place, publisher, year, edition, pages
2017. Vol. 198, no 6, p. 1333-1339
Keywords [en]
NanoZolid, Prostate cancer, bioresorbable, calcium sulphate, local treatment, modified-release
National Category
Medical and Health Sciences Urology and Nephrology Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-327250DOI: 10.1016/j.juro.2017.07.072ISI: 000417150900023PubMedID: 28736321OAI: oai:DiVA.org:uu-327250DiVA, id: diva2:1129851
Available from: 2017-08-07 Created: 2017-08-07 Last updated: 2018-03-06Bibliographically approved

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Häggman, MichaelLadjevardi, SamLennernäs, HansWeis, Janvon Below, CatrinWassberg, CeciliaTolf, AnnaAhlström, Håkan

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Häggman, MichaelLadjevardi, SamLennernäs, HansWeis, Janvon Below, CatrinWassberg, CeciliaTolf, AnnaAhlström, Håkan
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