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Robotic Seed Implantation for Prostate Cancer Brachytherapy (EUCLIDIAN)

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EUCLIDIAN Robot

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, EUCLIDIAN, Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing, robot, brachytherapy, seed implantation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant

Arm Description

Robotic implantation of brachytherapy seeds to treat prostate cancer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01341288

First Posted

March 29, 2011

Last Updated

April 10, 2017

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01341288

Brief Title

Robotic Seed Implantation for Prostate Cancer Brachytherapy

Acronym

EUCLIDIAN

Official Title

Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

July 29, 2008 (Actual)

Primary Completion Date

February 26, 2015 (Actual)

Study Completion Date

February 27, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implant

Arm Type

Experimental

Arm Description

Robotic implantation of brachytherapy seeds to treat prostate cancer

Intervention Type

Device

Intervention Name(s)

EUCLIDIAN Robot

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Coverage of the prostate by the prescribed radiation dose at V100

Description

Time Frame

Day 0 and Day 30 post-implant

Secondary Outcome Measure Information:

Title

Coverage of the prostate by the prescribed radiation dose at D90

Description

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.

Time Frame

12 months post-treatment

Title

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

Description

Time Frame

12 months

Title

International Prostate Symptom Score (IPSS)

Description

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Dicker, MD, PhD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21361179

Citation

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.

Results Reference

background

Links:

URL

http://www.JeffersonHospital.org

Description

Thomas Jefferson University Hospitals

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Robotic Seed Implantation for Prostate Cancer Brachytherapy

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