A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer

This is a first-in-human Phase 1/2, multinational, multicenter, open-label study of HB-302/HB-301 alternating 2-vector therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) comprising 2 phases: a Phase 1 Dose Escalation and recommended Phase 2 dose (RP2D) Confirmation, and a Phase 2 Dose Expansion.

Start Date23 May 2023

Sponsor / Collaborator

Hookipa Biotech AG

NCT02140138 / TerminatedPhase 2

An Open Label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in High Risk and Intermediate Risk Patients With Prostate Cancer

The purpose of this study is to evaluate the induction of immune responses against CV9104 administered by conventional intradermal injection or with a needle-free intradermal injection device and to assess the safety and tolerability of CV9104 administered by conventional intradermal injection versus injection with a needle-free intradermal injection device versus no injection.

Start Date01 Jun 2014

Sponsor / Collaborator

CureVac NV

100 Clinical Results associated with PSMA x ACP3 x KLK3

100 Translational Medicine associated with PSMA x ACP3 x KLK3

0 Patents (Medical) associated with PSMA x ACP3 x KLK3

Literatures (Medical) associated with PSMA x ACP3 x KLK3

03 Oct 2021·Expert Review of Clinical PharmacologyQ2 · MEDICINE

Targeting the spectrum of immune checkpoints in prostate cancer

Q2 · MEDICINE

Review

Author: Denmeade, Samuel R. ; Sena, Laura A. ; Antonarakis, Emmanuel S.

Introduction: The proven efficacy of the cellular vaccine sipuleucel-T in 2010 led to optimism about immunotherapeutic approaches for the treatment of prostate cancer. Some surmised that prostate cancer might be an ideal target for immune-mediated killing given that the prostate is not an essential organ and expresses unique proteins including prostate-specific antigen, prostate-specific membrane antigen, and prostatic acid phosphatase that could be targeted without side effects. Subsequently, antibodies that inhibit the T cell checkpoints PD1 and CTLA4 were shown to stimulate antitumor immune responses, leading to tumor regression in several cancer types. These therapies have since been tested in several studies as treatments for prostate cancer, but appear to have limited efficacy in molecularly unselected patients.Areas covered: In this review, we discuss these studies and evaluate features of prostate cancer and its host environment that may render it generally resistant to CTLA4 and PD1 blockade. We provide an overview of alternate immune checkpoints that may hold greater significance in this disease.Expert opinion: Combination therapies to target multiple layers of alternate immune checkpoints may be required for an effective immune response to prostate cancer. We discuss combination therapies currently being investigated.

01 Feb 2019·International Journal of Radiation Oncology*Biology*PhysicsQ2 · MEDICINE

50-Gy Stereotactic Body Radiation Therapy to the Dominant Intraprostatic Nodule: Results From a Phase 1a/b Trial

Q2 · MEDICINE

Article

Author: Lana Kandalaft ; Dominik Berthold ; Alexandre Harari ; Massimo Valerio ; Patrice Jichlinski ; Anne-Christine Thierry ; Petra Baumgartner ; Fernanda G. Herrera ; Veronique Vallet ; Jean-Yves Meuwly ; Thomas Tawadros ; George Coukos ; Jean Bourhis ; Berardino De Bari

PURPOSEAlthough localized prostate cancer (PCa) is multifocal, the dominant intraprostatic nodule (DIN) is responsible for disease progression after radiation therapy. PCa expresses antigens that could be recognized by the immune system. We therefore hypothesized that stereotactic dose escalation to the DIN is safe, may increase local control, and may initiate tumor-specific immune responses.PATIENTS AND METHODSPatients with localized PCa were treated with stereotactic extreme hypofractionated doses of 36.25 Gy in 5 fractions to the whole prostate while simultaneously escalating doses to the magnetic resonance image-visible DIN (45 Gy, 47.5 Gy, and 50 Gy in 5 fractions). The phase 1a part was designed to determine the recommended phase 1b dose in a "3 + 3" cohort-based, dose-escalation design. The primary endpoint was dose-limiting toxicities defined as ≥grade 3 gastrointestinal (GI) or genitourinary (GU) toxicity (or both) by National Cancer Institute Common Terminology Criteria for Adverse Events (version 4) up to 90 days after the first radiation fraction. The secondary endpoints were prostate-specific antigen kinetics, quality of life (QoL), and blood immunologic responses.RESULTSNine patients were treated in phase 1a. No dose-limiting toxicities were observed at either level, and therefore the maximum tolerated dose was not reached. Further characterization of tolerability, efficacy, and immunologic outcomes was conducted in the subsequent 11 patients irradiated at the highest dose level (50 Gy) in the phase 1b expansion cohort. Toxicity was 45% and 25% for grades 1 and 2 GU, and 20% and 5% for grades 1 and 2 GI, respectively. No grade 3 or worse toxicity was reported. The average (±standard error of the mean) of the QoL assessments at baseline and at 3-month posttreatment were 0.8 (±0.8) and 3.5 (±1.5) for the bowel (mean difference, 2.7; 95% confidence interval, 0.1-5), and 6.4 (±0.8) and 7.27 (±0.9) for the International Prostate Symptom Score (mean difference, 0.87; 95% confidence interval, 0.3-1.9), respectively. A subset of patients developed antigen-specific immune responses against prostate-specific membrane antigen (n = 2), prostatic acid phosphatase (n = 1), prostate stem cell antigen (n = 4), and prostate-specific antigen (n = 2).CONCLUSIONSIrradiation of the whole prostate with 36.25 Gy in 5 fractions and dose escalation to 50 Gy to the DIN was tolerable and determined as the recommended phase 1b dose. This treatment has promising antitumor activity, which will be confirmed by the ongoing phase 2 part. Preliminary QoL analysis showed minimal impact in GU, GI, and sexual domains. Stereotactic irradiation induced antigen-specific immune responses in a subset of patients.

01 Sep 2016·Actas Dermo-Sifiliográficas

Metástasis cutáneas a distancia de cáncer de próstata: 2 casos

Article

Author: Rey-Sanjurjo, J L ; Fernández-Díaz, M L ; Castiñeiras, I ; Rodríguez-Lojo, R

Cutaneous metastases of prostate cancer are extremely rare. We present 2 cases of distant cutaneous metastases at atypical locations of prostate adenocarcinoma, and highlight the value of 2 immunohistochemical stains-prostatic acid phosphatase and prostate-specific membrane antigen-that can aid diagnosis, particularly in cases with negative staining for prostate-specific antigen.

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