Prostate CancerNCT02790216
Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy
An observational study of Prostate Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Objective: To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate. In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of… Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to Jun 2020
- Phase
- Observational
- 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 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men eligible for prostate brachytherapy
Who may be able to join
- Men suitable for monotherapy with permanent Iodine 125 implant
- Age > 50 yrs
- PS 0-2 (WHO)
- Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
- No more than 50% of cores involved (summary)
- MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
Show all 12Show fewer
- Gleason sum no greater than 3+4 =7 in any core
- Clinical T stage no higher than T T (tumor) 2A
- Prostate volume ≤60 cc
- Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
- No prior history of malignancy except non-melanoma skin cancer
- Must be suitable for general or spinal anesthesia
Who cannot join
- Have anesthesia surgical assignment category IV or greater
- Cannot cease anti-coagulant therapy
- Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
- urethral stricture
- Prior prostate cancer therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Focused Dose Painted I-125 Brachytherapy for Low to Intermediate Risk Prostate Cancer Using Deformable Registration of Multi-parametric MRI (Magnetic Resonance Imaging) to Intra-operative TRUS (Trans Rectal Ultrasound)
Objective:
To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.
Read the detailed description
Primary end-point:
Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
- There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
- There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.
- Conditions
- Prostate Cancer
- Being tested
- Brachytherapy
- Keywords
- Image guided brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyProcedure or surgery
Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy | men eligible for monotherapy seed implant brachytherapy Receives: Procedure: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume
Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor
Measured: Pathological report due one month after brachytherapy implant
Secondary outcomes (2)
Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml
Measured: 3 years
Urinary , Sexual ,Bowel and Vitality function domains
Expanded Prostate Inventory Composite (EPIC)
Measured: 6 months and then at years one , two and three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zvi Symon, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790216
- Sponsor's protocol ID
- SHEBA-15-2845-ZS-CTIL
- Status last verified
- May 2016
- First submitted
- 6 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Focused Dose Painted I-125 Brachytherapy for Low to Intermediate Risk Prostate Cancer Using Deformable Registration of Multi-parametric MRI (Magnetic Resonance Imaging) to Intra-operative TRUS (Trans Rectal Ultrasound)
- ClinicalTrials.gov ID
- NCT02790216
- Acronym / sponsor ID
- SHEBA-15-2845-ZS-CTIL
- Conditions
- Prostate Cancer
- Keywords
- Image guided brachytherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 3 Jun 2016 (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.
Objective:
To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.
Detailed description
Primary end-point:
Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
- There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
- There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy | – | Procedure: Brachytherapymen eligible for monotherapy seed implant brachytherapy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men eligible for prostate brachytherapy
Key inclusion criteria (12 listed)
- Men suitable for monotherapy with permanent Iodine 125 implant
Key exclusion criteria (5 listed)
- Have anesthesia surgical assignment category IV or greater
- Cannot cease anti-coagulant therapy
- Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
- urethral stricture
- Prior prostate cancer therapies
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 |
|---|---|---|
| BrachytherapyBiopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume | Procedure or surgery | Brachytherapy |
Primary outcome
Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume
Time frame: Pathological report due one month after brachytherapy implant
Negative biopsy outside the high risk planning target volume will confirm the accuracy of the MRI TRUS elastic fusion algorithm to locate the tumor
2 secondary outcomes
Biochemical failure as determined by Prostate specific antigen greater than nadir+2 ng/ml
Time frame: 3 years
Urinary , Sexual ,Bowel and Vitality function domains
Time frame: 6 months and then at years one , two and three
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Zvi Symon, MD principal investigator
Chaim Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Sheba Medical Center at 1 site in Israel.
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 12 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Symon, MD (97235308175, symonz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with a positive biopsy outside the defined High risk Planning Target Volume (time frame: Pathological report due one month after brachytherapy implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.