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NBTXR3 Nanoparticles and EBRT or EBRT With Brachytherapy in the Treatment of Prostate Adenocarcinoma

NCT02805894 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-05-10

No results posted yet for this study

Summary

This study is a Phase 1/2 open-label involving 2 groups of patients newly diagnosed with either unfavorable intermediate risk or high risk prostate adenocarcinoma. One group will receive only EBRT and the other group will receive a Brachytherapy boost and EBRT. Both groups will receive treatment with androgen deprivation. There will be 2 consecutive steps, a dose escalation and a subsequent dose expansion part.

Conditions

Interventions

DRUG

NBTXR3 activated by IMRT only

Single local administration of NBTXR3 by injection into the prostate gland prior to the IMRT treatment

DRUG

NBTXR3 activated by Brachytherapy & IMRT

Single local administration of NBTXR3 by injection into the prostate gland prior to the Brachytherapy \& IMRT treatment

Sponsors & Collaborators

  • Nanobiotix

    lead INDUSTRY

Principal Investigators

  • Adam Dicker, MD · Thomas Jefferson University Hospital Philadelphia, PA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2020-03-19
Completion
2020-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02805894 on ClinicalTrials.gov