CancerNCT02370992
I125 Brachytherapy After TURP
An observational study of Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow… Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Cancer
- What is being tested?
- I125 brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2011to 1 Jul 2016
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment for prostate cancer and will have previously undergone TURP
Who may be able to join
- WHO performance status 0-1
- No contra-indication for anaesthesia
- No history of irradiation of the pelvis
- No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Prostate (cancer) related:
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- Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.
- Prostate volume < 50 cc as measured on transrectal ultrasound
- Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.
- History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.
- Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate
- Absence of significant TURp-induced urinary incontinence
- IPSS <15
Who cannot join
- Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.
- Unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
About this study
Official title: Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.
- Conditions
- Cancer
- Being tested
- I125 brachytherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I125 brachytherapyRadiation
I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice
| Study group | Role | What they receive |
|---|---|---|
| Receiving I125 brachytherapy | I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice Receives: Radiation: I125 brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.
This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
Measured: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
Secondary outcomes (4)
Gastro-intestinal and sexual function
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Measured: Measured at 1 mth.
Gastro-intestinal and sexual function
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Measured: Measured at 3 mth.
Gastro-intestinal and sexual function
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Measured: Measured at 6 mth.
Gastro-intestinal and sexual function
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Measured: Measured at 12 mth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start1 Jul 2011
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370992
- Sponsor's protocol ID
- CO11/9837
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2015
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
- ClinicalTrials.gov ID
- NCT02370992
- Acronym / sponsor ID
- CO11/9837
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 25 Feb 2015 (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.
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving I125 brachytherapy | – | Radiation: I125 brachytherapyI125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment for prostate cancer and will have previously undergone TURP
Key inclusion criteria (13 listed)
- WHO performance status 0-1
- No contra-indication for anaesthesia
- No history of irradiation of the pelvis
- No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Key exclusion criteria (2 listed)
- Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.
- Unable to give informed consent.
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 |
|---|---|---|
| I125 brachytherapyI125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice | Radiation | Receiving I125 brachytherapy |
Primary outcome
Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.
Time frame: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
4 secondary outcomes
Gastro-intestinal and sexual function
Time frame: Measured at 1 mth.
Gastro-intestinal and sexual function
Time frame: Measured at 3 mth.
Gastro-intestinal and sexual function
Time frame: Measured at 6 mth.
Gastro-intestinal and sexual function
Time frame: Measured at 12 mth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 13 inclusion and 2 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: finished, as of the sponsor's last update on 19 Aug 2019. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4. (time frame: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly). 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 19 Aug 2019.