Robotic Seed Implantation for Prostate Cancer Brachytherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-29

Study Completion Date

2015-02-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implant

Robotic implantation of brachytherapy seeds to treat prostate cancer

Group Type EXPERIMENTAL

EUCLIDIAN Robot

Intervention Type DEVICE

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

Interventions

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EUCLIDIAN Robot

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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No