Prostate CancerPhase 1EUCLIDIANNCT01341288
Robotic Seed Implantation for Prostate Cancer Brachytherapy
A Phase 1 study testing EUCLIDIAN Robot in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- EUCLIDIAN Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2008to 27 Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- EUCLIDIAN Robot
- Keywords
- prostate cancer, EUCLIDIAN, Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing, robot, brachytherapy, seed implantation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUCLIDIAN RobotDevice
Also called Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing
EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing) system for placement of radioactive seeds in the prostate
| Study group | Role | What they receive |
|---|---|---|
| Implant | Experimental | Robotic implantation of brachytherapy seeds to treat prostate cancer Receives: Device: EUCLIDIAN Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and Day 30 post-implant
Secondary outcomes (3)
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.
Measured: 12 months post-treatment
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study start29 Jul 2008
- Primary completion26 Feb 2015
- Study completion27 Feb 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adam Dicker, MD, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341288
- Sponsor's protocol ID
- 08F.298
- Other IDs
- 2007-24, R01CA091763, JT 1232
- Acronym
- EUCLIDIAN
- Status last verified
- May 2025
- First submitted
- 29 Mar 2011
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 21361179
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT01341288
- Acronym / sponsor ID
- EUCLIDIAN / 08F.298
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, EUCLIDIAN, Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing, robot, brachytherapy, seed implantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jul 2008 (actual)
- Primary completion
- 26 Feb 2015 (actual)
- Study completion
- 27 Feb 2015 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: EUCLIDIAN RobotRobotic implantation of brachytherapy seeds to treat prostate cancer |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUCLIDIAN RobotAlso: Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with NanosensingEUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing) system for placement of radioactive seeds in the prostate | Device | Implant |
Primary outcome
Coverage of the prostate by the prescribed radiation dose at V100
Time frame: Day 0 and Day 30 post-implant
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.
3 secondary outcomes
Coverage of the prostate by the prescribed radiation dose at D90
Time frame: 12 months post-treatment
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: 12 months
International Prostate Symptom Score (IPSS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 21361179Podder 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.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Dicker, MD, PhD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EUCLIDIAN Robot in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coverage of the prostate by the prescribed radiation dose at V100 (time frame: Day 0 and Day 30 post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.