Robotic Seed Implantation for Prostate Cancer Brachytherapy (EUCLIDIAN)

Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy

A robotic brachytherapy device will be used to assist physicians in performing seed implantation to the prostate. EUCLIDIAN is the first robotic system designed to allow automatic placement of radioactive seeds by robot and thus reduce operator dependence. The clinical study is designed to evaluate the dosimetric quality, accuracy and patient self-reported quality of life scores after robotic brachytherapy.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: EUCLIDIAN Robot

Detailed Description

EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing)

The dose-volume histogram parameters of robotic brachytherapy will be compared to historical controls of the study institution. Short-term (<1 yr) health-related quality of life (HRQoL) and changes will be assessed using FACT-P and IPSS self-report questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T2b, NX, N0, M0.
• Zubrod status 0-1.
• Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration
• No prior pelvic radiation or chemotherapy for any reason; induction hormonal therapy beginning < or = 6 months prior to registration is acceptable.
• Prostate volume < or = 65 cc prior to registration, or planned use of LHRH agonist therapy for reduction of prostate volume. If LHRH agonist therapy is used to reduce prostate volume, then prostate volume must be < or = 65 cc on the routine pre-implant volume study to be eligible for the study.
• Gleason score 6, or Gleason Score 7 if both , or = 33% of biopsy cores contain cancer and PSA level is < or = 10 ng/mL.
• AUA voiding symptoms score < or = 15.
• Prostate specific antigen (PSA) prior to study entry (and prior to any hormone treatment if given); must be < or = 20 ng/ml.
• Patients must sign a study-specific consent form prior to registration (Standard of care: only the standard consent form must be signed).
• Patient must be > or = 40 years old.

Exclusion Criteria:

• Stage T2c, T3 or T4 disease.
• Lymph node involvement (pathological N1)
• Evidence of distant metastases (M1)
• Gleason score 8-10.
• Prostate specific antigen (PSA) prior to study entry > 20 ng/mL.
• AUA voiding symptoms score > 15.
• Radical surgery for carcinoma of the prostate.
• Previous hormonal therapy beginning > 6 months prior to registration
• Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease- free for > or = 5 years.
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up and/or completion of HRQoL questionnaires (not a condition for ineligibility in Standard of care).
• Prior TURP
• Hip prosthesis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implant; Robotic implantation of brachytherapy seeds to treat prostate cancer	Device: EUCLIDIAN Robot; EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing) system for placement of radioactive seeds in the prostate; Other Names: Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coverage of the prostate by the prescribed radiation dose at V100	The principal endpoint is the dose-volume histogram (DVH) measured at V100 (percent volume of the target receiving the intended dose). These values will also be compared retrospectively to those in the conventional group. Improved quality will be demonstrated by increased V100 in the protocol patients.	Day 0 and Day 30 post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coverage of the prostate by the prescribed radiation dose at D90	The secondary endpoint is the dose-volume histogram (DVH) measured at D90 (dose to 90% of the target volume). These values will also be compared retrospectively to those in the conventional group.	12 months post-treatment
Functional Assessment of Cancer Therapy-Prostate (FACT-P)	Patient self-reported, health-related, quality of life measures using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) self-report questionnaire. FACT-P instruments prior to treatment (T0), 1 month (T1), 3 months (T3), 6 months (T6) and 12 months (T12) following treatment with robot-assisted brachytherapy.	12 months
International Prostate Symptom Score (IPSS)	Patient self-reported, health-related, quality of life measures using the International Prostate Symptom Score (IPSS) self-report questionnaire. IPSS instruments prior to treatment (T0), 1 month (T1), 3 months (T3), 6 months (T6) and 12 months (T12) following treatment with robot-assisted brachytherapy.	12 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Adam Dicker, MD, PhD, Thomas Jefferson University

Publications and helpful links

General Publications

• Podder TK, Buzurovic I, Huang K, Showalter T, Dicker AP, Yu Y. Reliability of EUCLIDIAN: an autonomous robotic system for image-guided prostate brachytherapy. Med Phys. 2011 Jan;38(1):96-106. doi: 10.1118/1.3523097.

Helpful Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2008
• Primary Completion (Actual): February 26, 2015
• Study Completion (Actual): February 27, 2015

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimated): April 25, 2011

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; brachytherapy; robot; seed implantation; EUCLIDIAN; Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 08F.298; 2007-24 (Other Identifier: CCRRC); R01CA091763 (U.S. NIH Grant/Contract); JT 1232 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes