NCT03541928

Phase II Study Evaluating HSV-tk + Valacyclovir Gene Therapy in Combination With Androgen Deprivation Therapy, Brachytherapy, External Beam Radiotherapy, and Prostatectomy for High-Risk Prostate Cancer

Status unknown Phase 2 Last updated 5 April 2021

What this trial tests

Phase 2 trial testing HSV-Tk in High-risk Prostate Cancer in 60 participants. Status unknown.

Timeline

2 August 2018

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	2 August 2018
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	1 location across United States

Drugs / interventions tested

• HSV-Tk
• Valacyclovir — full drug profile →
• Bicalutamide (bicalutamide) — full drug profile →
• Leuprolide Acetate (leuprolide-acetate) — full drug profile →
• Brachytherapy, External beam radiotherapy
• Radical prostatectomy

Conditions studied

• High-risk Prostate Cancer — all drugs for High-risk Prostate Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

The Methodist Hospital Research Institute

Who can join

18 and older, male only, with High-risk Prostate Cancer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Biochemical control rate
  Time frame: 5-year biochemical disease free survival rate
  measured by PSA

Sponsor's own description

This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate cancer.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral vector-based gene therapies in the clinic.
   Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
2. Alpha-Herpesvirus Thymidine Kinase Genes Mediate Viral Virulence and Are Potential Therapeutic Targets.
   Xie Y, Wu L, Wang M, Cheng A, et al · · 2019 · cited 47× · PMID 31134006 · DOI 10.3389/fmicb.2019.00941
3. Gene delivery for immunoengineering.
   Neshat SY, Tzeng SY, Green JJ. · · 2020 · cited 29× · PMID 32554325 · DOI 10.1016/j.copbio.2020.05.008
4. Oncolytic virus-based suicide gene therapy for cancer treatment: a perspective of the clinical trials conducted at Henry Ford Health.
   Thoidingjam S, Sriramulu S, Freytag S, Brown SL, et al · · 2023 · cited 17× · PMID 37065938 · DOI 10.1186/s41231-023-00144-w
5. Comprehensive assessment on the applications of oncolytic viruses for cancer immunotherapy.
   Omole RK, Oluwatola O, Akere MT, Eniafe J, et al · · 2022 · cited 15× · PMID 36569326 · DOI 10.3389/fphar.2022.1082797
6. Repurposing ¹⁸F-FMISO as a PET tracer for translational imaging of nitroreductase-based gene directed enzyme prodrug therapy.
   Ruiz de Garibay G, García de Jalón E, Stigen E, Lund KB, et al · · 2021 · cited 9× · PMID 33897898 · DOI 10.7150/thno.55092