Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Echolaser X4 system

J R Oddens, MD, PhD

Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration.

The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement.

This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia.

This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.

Transperineal Laser Ablation for Focal Treatment of Prostate Cancer

Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis

Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone

Safety is assessed by device and procedural adverse events using the CTCAE v5.0 until radical prostatectomy. TPLA is definitely safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher. Technical feasibility is determined by procedural success of the TPLA treatment.

TPLA is definitely feasible when ≥90% of procedures is performed successfully without any problems regarding needle placement, fibre introduction or device malfunctioning.

Determination of the size of the ablated area

Ablation zone volumes are measured using CEUS and mpMRI and these are used to determine ablation zone compared to histopathological changes. Visual changes are identified and described.

Determination of short-term functional outcomes following TPLA treatment

Elesta S.R.L.

Amsterdam UMC, location VUmc

The Netherlands Cancer Institute

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Head of Urology department

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

ARX517 will be administered via intravenous (IV) infusion every 3, or 4 weeks.

ARX517 is an ADC consisting of a humanized anti-PSMA monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two (2) proprietary microtubule-disrupting toxins referred to as AS269.

ARX517

Trial Inquiry

Ambrx

This is a phase 1 study to assess the safety and tolerability of ARX517 in adult subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

This is a first-in-human, Phase 1, multicenter, open-label study to evaluate the safety, PK, PDy, and preliminary anti-tumor activity of ARX517 in adult subjects with mCRPC with serum testosterone level \< 50 ng/dL at screening who are resistant or refractory to standard therapies. Phase 1a (dose-escalation) and Phase 1b (dose-expansion) stages will identify the MTD and/or RDDs.

ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer

A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Are Resistant or Refractory to Prior Standard Therapies

To evaluate exploratory blood based biomarkers related to study drug response

To evaluate relationship of PSMA expression and anti-tumor activity

A Brief Pain Inventory questionnaire will be utilized to assess subject quality of life. Higher scores mean a worse outcome

FACT-P questionnaire will be utilized to assess subject quality of life. Higher scores mean a worse outcome

Incidence and severity of adverse events or serious adverse events of ARX517 will be assessed to determine the safety and tolerability of the treatment using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE).

Pharmacokinetic parameter area under the serum concentration-time curve (AUC) will be analyzed through different analytes such as ADC, total antibody, and pAF-AS269

Pharmacokinetic parameter maximum serum concentration (Cmax) will be analyzed through different analytes such as, ADC, total antibody, and pAF-AS269

Pharmacokinetic parameter trough concentration (Ctrough) will be analyzed through different analytes such as, ADC, total antibody, and pAF-AS269

To assess the incidence of anti-drug antibodies (ADA) against ARX517 at selected timepoints

Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause). Subjects who are alive will be censored at the last known time that the subject was alive.

Proportion of subjects who show a confirmed reduction of 30% and 50% from baseline in serum prostate specific antigen (PSA) levels (PSA30, PSA50)

PFS is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable subjects. Subjects will be censored at time of subsequent therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transperineal Laser Ablation for Focal Treatment of Prostate Cancer	NCT04170478	Prostate Cancer Focal Laser Abl... Transperineal L...	Echolaser X4 sy...	40 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer	NCT04662580	Prostate Cancer	ARX517	18 Years -	Ambrx, Inc.
ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer	NCT04662580	Prostate Cancer	ARX517	18 Years -	Ambrx, Inc.
ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer	NCT04662580	Prostate Cancer	ARX517	18 Years -	Ambrx, Inc.

Spots Global Cancer Trial Database for prostate neoplasma