Robotic Seed Implantation for Prostate Cancer Brachytherapy (EUCLIDIAN)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase

Terminated

Phase 1

Conditions

Prostate Cancer

Treatments

Device: EUCLIDIAN Robot

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01341288

08F.298

R01CA091763 (U.S. NIH Grant/Contract)

JT 1232 (Other Identifier)

2007-24 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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