Clinical trial NCT01341288: Robotic Seed Implantation for Prostate Cancer Brachytherapy
Official title: Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate cancer
EUCLIDIAN
Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing
robot
brachytherapy
seed implantation
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-04-25
Enrollment: 2
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Coverage of the prostate by the prescribed radiation dose at V100
timeFrame: Day 0 and Day 30 post-implant
Secondary outcomes:
measure: Coverage of the prostate by the prescribed radiation dose at D90
timeFrame: 12 months post-treatment
measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: 12 months
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam Dicker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.