Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients

Laurence Klotz; Stefan Grudén; Niklas Axén; Charlotta Gauffin; Cecilia Wassberg; Anders Bjartell; Jonathan Giddens; Peter Incze; Kenneth Jansz; Mindaugas Jievaltas; Ricardo Rendon; Patrick O Richard; Albertas Ulys; Teuvo L Tammela

doi:10.1016/j.euf.2021.02.003

Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients

Laurence Klotz, Stefan Grudén, Niklas Axén, Charlotta Gauffin, Cecilia Wassberg, Anders Bjartell, Jonathan Giddens, Peter Incze, Kenneth Jansz, Mindaugas Jievaltas, Ricardo Rendon, Patrick O Richard, Albertas Ulys, Teuvo L Tammela

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Abstract

BACKGROUND: There is increasing interest in nonmorbid treatments for low- and intermediate-risk prostate cancer with fewer side effects than surgery or radiotherapy.

OBJECTIVE: To investigate the tolerability, safety, and antitumor effects of the intraprostatic NanoZolid depot formulation Liproca Depot (LIDDS AB, Uppsala, Sweden) with antiandrogen 2-hydroxyflutamide (2-HOF) in men with low- or intermediate-risk localized prostate cancer managed with active surveillance.

DESIGN, SETTING, AND PARTICIPANTS: This clinical phase 2b trial, LPC-004, involved 61 patients. The 2-HOF-containing formulation Liproca Depot was injected transrectally into the prostate under ultrasound guidance. A single dose of 35% or 45% of the prostate volume (study part 1) and a fixed dose of 16 or 20 ml (study part 2) of the formulation were evaluated.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The primary endpoints were tolerability and the reduction in serum prostate-specific antigen (PSA) 5 mo after injection. Antitumor effects were evaluated with magnetic resonance imaging (MRI) and prostate biopsies. Quality of life was assessed using a validated questionnaire (International Prostate Symptom Score).

RESULTS AND LIMITATIONS: All doses were safe and well tolerated, without hormonal side effects. In part 2 of the study, the PSA reduction was greatest for the group receiving 16 ml, with an average decrease of 14%, and 95% of patients had a PSA reduction. Some 78% of patients showed a prostate volume decrease compared to baseline. Prostate MRI and biopsies confirmed stable or reduced lesion size. However, post treatment biopsies were performed at the discretion of the investigator, and not routinely. Most patients were amenable to a second injection.

CONCLUSIONS: PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases.

PATIENT SUMMARY: Liproca Depot is a safe, minimally invasive treatment that offers the potential for cancer control in patients with intermediate-risk prostate cancer. Further clinical evaluation is warranted.

Original language	English
Pages (from-to)	112-120
Journal	European Urology Focus
Volume	8
Issue number	1
Early online date	11 Feb 2021
DOIs	https://doi.org/10.1016/j.euf.2021.02.003
Publication status	Published - 2022
Publication type	A1 Journal article-refereed

Keywords

prostatic neoplasms
androgen antagonists
calcium sulfate
drug delivery systems
delayed-action preparations

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Publication forum level 1

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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1-s2.0-S2405456921000468-mainFinal published version, 848 KBLicence: CC BY-NC-ND

http://urn.fi/URN:NBN:fi:tuni-202105054461Licence: CC BY-NC-ND

Cite this

@article{938624e8a4174a07a5f281f32477ca4d,

title = "Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients",

abstract = "BACKGROUND: There is increasing interest in nonmorbid treatments for low- and intermediate-risk prostate cancer with fewer side effects than surgery or radiotherapy.OBJECTIVE: To investigate the tolerability, safety, and antitumor effects of the intraprostatic NanoZolid depot formulation Liproca Depot (LIDDS AB, Uppsala, Sweden) with antiandrogen 2-hydroxyflutamide (2-HOF) in men with low- or intermediate-risk localized prostate cancer managed with active surveillance.DESIGN, SETTING, AND PARTICIPANTS: This clinical phase 2b trial, LPC-004, involved 61 patients. The 2-HOF-containing formulation Liproca Depot was injected transrectally into the prostate under ultrasound guidance. A single dose of 35% or 45% of the prostate volume (study part 1) and a fixed dose of 16 or 20 ml (study part 2) of the formulation were evaluated.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The primary endpoints were tolerability and the reduction in serum prostate-specific antigen (PSA) 5 mo after injection. Antitumor effects were evaluated with magnetic resonance imaging (MRI) and prostate biopsies. Quality of life was assessed using a validated questionnaire (International Prostate Symptom Score).RESULTS AND LIMITATIONS: All doses were safe and well tolerated, without hormonal side effects. In part 2 of the study, the PSA reduction was greatest for the group receiving 16 ml, with an average decrease of 14%, and 95% of patients had a PSA reduction. Some 78% of patients showed a prostate volume decrease compared to baseline. Prostate MRI and biopsies confirmed stable or reduced lesion size. However, post treatment biopsies were performed at the discretion of the investigator, and not routinely. Most patients were amenable to a second injection.CONCLUSIONS: PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases.PATIENT SUMMARY: Liproca Depot is a safe, minimally invasive treatment that offers the potential for cancer control in patients with intermediate-risk prostate cancer. Further clinical evaluation is warranted.",

keywords = "prostatic neoplasms, androgen antagonists, calcium sulfate, drug delivery systems, delayed-action preparations",

author = "Laurence Klotz and Stefan Grud{\'e}n and Niklas Ax{\'e}n and Charlotta Gauffin and Cecilia Wassberg and Anders Bjartell and Jonathan Giddens and Peter Incze and Kenneth Jansz and Mindaugas Jievaltas and Ricardo Rendon and Richard, {Patrick O} and Albertas Ulys and Tammela, {Teuvo L}",

year = "2022",

doi = "10.1016/j.euf.2021.02.003",

language = "English",

volume = "8",

pages = "112--120",

number = "1",

}

TY - JOUR

T1 - Liproca Depot

T2 - A New Antiandrogen Treatment for Active Surveillance Patients

AU - Klotz, Laurence

AU - Grudén, Stefan

AU - Axén, Niklas

AU - Gauffin, Charlotta

AU - Wassberg, Cecilia

AU - Bjartell, Anders

AU - Giddens, Jonathan

AU - Incze, Peter

AU - Jansz, Kenneth

AU - Jievaltas, Mindaugas

AU - Rendon, Ricardo

AU - Richard, Patrick O

AU - Ulys, Albertas

AU - Tammela, Teuvo L

PY - 2022

Y1 - 2022

N2 - BACKGROUND: There is increasing interest in nonmorbid treatments for low- and intermediate-risk prostate cancer with fewer side effects than surgery or radiotherapy.OBJECTIVE: To investigate the tolerability, safety, and antitumor effects of the intraprostatic NanoZolid depot formulation Liproca Depot (LIDDS AB, Uppsala, Sweden) with antiandrogen 2-hydroxyflutamide (2-HOF) in men with low- or intermediate-risk localized prostate cancer managed with active surveillance.DESIGN, SETTING, AND PARTICIPANTS: This clinical phase 2b trial, LPC-004, involved 61 patients. The 2-HOF-containing formulation Liproca Depot was injected transrectally into the prostate under ultrasound guidance. A single dose of 35% or 45% of the prostate volume (study part 1) and a fixed dose of 16 or 20 ml (study part 2) of the formulation were evaluated.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The primary endpoints were tolerability and the reduction in serum prostate-specific antigen (PSA) 5 mo after injection. Antitumor effects were evaluated with magnetic resonance imaging (MRI) and prostate biopsies. Quality of life was assessed using a validated questionnaire (International Prostate Symptom Score).RESULTS AND LIMITATIONS: All doses were safe and well tolerated, without hormonal side effects. In part 2 of the study, the PSA reduction was greatest for the group receiving 16 ml, with an average decrease of 14%, and 95% of patients had a PSA reduction. Some 78% of patients showed a prostate volume decrease compared to baseline. Prostate MRI and biopsies confirmed stable or reduced lesion size. However, post treatment biopsies were performed at the discretion of the investigator, and not routinely. Most patients were amenable to a second injection.CONCLUSIONS: PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases.PATIENT SUMMARY: Liproca Depot is a safe, minimally invasive treatment that offers the potential for cancer control in patients with intermediate-risk prostate cancer. Further clinical evaluation is warranted.

AB - BACKGROUND: There is increasing interest in nonmorbid treatments for low- and intermediate-risk prostate cancer with fewer side effects than surgery or radiotherapy.OBJECTIVE: To investigate the tolerability, safety, and antitumor effects of the intraprostatic NanoZolid depot formulation Liproca Depot (LIDDS AB, Uppsala, Sweden) with antiandrogen 2-hydroxyflutamide (2-HOF) in men with low- or intermediate-risk localized prostate cancer managed with active surveillance.DESIGN, SETTING, AND PARTICIPANTS: This clinical phase 2b trial, LPC-004, involved 61 patients. The 2-HOF-containing formulation Liproca Depot was injected transrectally into the prostate under ultrasound guidance. A single dose of 35% or 45% of the prostate volume (study part 1) and a fixed dose of 16 or 20 ml (study part 2) of the formulation were evaluated.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The primary endpoints were tolerability and the reduction in serum prostate-specific antigen (PSA) 5 mo after injection. Antitumor effects were evaluated with magnetic resonance imaging (MRI) and prostate biopsies. Quality of life was assessed using a validated questionnaire (International Prostate Symptom Score).RESULTS AND LIMITATIONS: All doses were safe and well tolerated, without hormonal side effects. In part 2 of the study, the PSA reduction was greatest for the group receiving 16 ml, with an average decrease of 14%, and 95% of patients had a PSA reduction. Some 78% of patients showed a prostate volume decrease compared to baseline. Prostate MRI and biopsies confirmed stable or reduced lesion size. However, post treatment biopsies were performed at the discretion of the investigator, and not routinely. Most patients were amenable to a second injection.CONCLUSIONS: PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases.PATIENT SUMMARY: Liproca Depot is a safe, minimally invasive treatment that offers the potential for cancer control in patients with intermediate-risk prostate cancer. Further clinical evaluation is warranted.

KW - prostatic neoplasms

KW - androgen antagonists

KW - calcium sulfate

KW - drug delivery systems

KW - delayed-action preparations

U2 - 10.1016/j.euf.2021.02.003

DO - 10.1016/j.euf.2021.02.003

M3 - Article

C2 - 33583762

SN - 2405-4569

VL - 8

SP - 112

EP - 120

JO - European Urology Focus

JF - European Urology Focus

IS - 1

ER -

Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients

Abstract

Keywords

Publication forum classification

UN SDGs

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