Robotic Seed Implantation for Prostate Cancer Brachytherapy

Prostate Cancer Clinical Trial

— EUCLIDIAN  

Official title:

Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01341288
• Other study ID #: 08F.298
• Secondary ID: 2007-24R01CA0917
• Status: Terminated
• Phase: Phase 1
• First received: March 29, 2011
• Last updated: April 10, 2017
• Start date: July 29, 2008
• Est. completion date: February 27, 2015

Study information

• Verified date: April 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 27, 2015
• Est. primary completion date: February 26, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months post-treatment
Secondary	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.	12 months
Secondary	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.	12 months

External Links

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