Robotic Seed Implantation for Prostate Cancer Brachytherapy

NCT01341288 | Terminated Phase 1 DMC FDA Device

• 4 other identifiers: 08F.2982007-24R01CA091763JT 1232
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; EUCLIDIAN; Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing; robot; brachytherapy; seed implantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Coverage of the prostate by the prescribed radiation dose at D90

  12 months post-treatment

• Functional Assessment of Cancer Therapy-Prostate (FACT-P)

  12 months

• International Prostate Symptom Score (IPSS)

  12 months

Study Arms (1)

Implant

EXPERIMENTAL

Robotic implantation of brachytherapy seeds to treat prostate cancer

Device: EUCLIDIAN Robot

Interventions

EUCLIDIAN Robot DEVICE

EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing) system for placement of radioactive seeds in the prostate

Also known as: Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing

Implant

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 21361179 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Adam Dicker, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 25, 2011
• Study Start: July 29, 2008
• Primary Completion: February 26, 2015
• Study Completion: February 27, 2015
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)