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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Robotic implantation of brachytherapy seeds to treat prostate cancer

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

EUCLIDIAN Robot

Adam Dicker, MD, PhD

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.

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.

Robotic Seed Implantation for Prostate Cancer Brachytherapy

Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy

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.

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.

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.

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.

National Cancer Institute (NCI)

Sidney Kimmel Cancer Center at Thomas Jefferson University

William Demas, MD

The primary goal of this project is to evaluate the efficacy of prostate seed implantation for the treatment of early stage prostate cancer for patients treated at Summa Health System/Akron City Hospital and Salem Community Hospital.

Charts of early stage prostate cancer patients receiving prostate seed implants with or without external beam radiotherapy and/or hormonal therapy will be reviewed and abstracted. The abstracted data will include pathology reports including Gleason score and T stage, PSA, treatment assignment and dosimetry parameters including dose and percent compliant with established criteria based on guidelines established by the American Brachytherapy Society.

A database will be developed for capture of the abstracted data. Outcomes will be determined based on PSA levels at 2 and 5 years after prostate seed implantation. The role of hormonal therapy with prostate seed implantation and outcomes will be evaluated. The outcomes will be compared to national statistics.

Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer

A retrospective chart review of PSA values on 85 patients from 2001-2008 with prostate cancer stage T1c-T2a NX MO, who were treated with permanent prostate brachytherapy using conventional transrectal ultrasound guided placement of Iodine-125 seeds delivering 145 Gy or 110 Gy, depending on whether mono or combination therapy with external beam radiotherapy (EBRT) was used. Those who had EBRT received 45 Gy prior to seed implants. Some patients also received hormonal therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Robotic Seed Implantation for Prostate Cancer Brachytherapy	NCT01341288	Prostate Cancer	EUCLIDIAN Robot	40 Years -	Thomas Jefferson University
Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer	NCT00773305	Prostate Cancer		18 Years - 80 Years	Summa Health System

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