Prostate CancerPhase 2NCT02643511
Hemiablative Focal Brachytherapy Pilot Study
A Phase 2 study testing Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy in people with Prostate Cancer, run by St George Hospital, Australia at 1 site in Australia.
Trial summary
Whole gland LDR brachytherapy has been a well established modality of treating low risk prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to surrounding organs. Read more about this study
- Who is it for?
- Ages 60 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2015to Jul 2025
- Phase
- Phase 2
- 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 60 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients must have histologically proven adenocarcinoma of the prostate.
- 2. Patients must have low or low-tier intermediate prostate cancer
- Low risk prostate cancer patients must have:
- Clinical stage ≤ T2a,
- Gleason score =6 and iPSA ≤ 10 ng/ml
- < 25% cores positive, < 50 % cancer in each core involved
Show all 15Show fewer
- Low tier Intermediate risk patients may have:
- Clinical stageT2a
- Gleason score ≤ 3+4=7
- PSA ≤ 10 ng/ml
- < 25% cores positive, < 50 % cancer in each core
- 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- 6. Men ≥ 65 years of age with a life expectancy estimated to be >10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy.
- 8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days.
- 9. Patients must not have any contraindications to MRI 10. IPSS <=16
Who cannot join
- Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
- Bilateral prostatic disease
- Prior hormonal therapy
- Prior Transurethral resection or middle lobe resection
- Recent IPSS>
- Unfit for general anesthetic
Show all 10Show fewer
- MRI contraindicated
- Unable to cease anticoagulant therapy
- Life expectancy < 10 years
- IPSS>16
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
St George Hospital Cancer Care Centre
Kogarah, Sydney, New South Wales, 2217
Ana Fernandez, MD, +61291131306, ana.fernandezots@sesiahs.health.nsw.gov.au
About this study
Official title: Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer
Whole gland LDR brachytherapy has been a well established modality of treating low risk prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to surrounding organs.
AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment for localized prostate cancer demonstrating the feasibility of the delivery of the prescription dose to the half of the prostate in terms of meeting standard dosimetric parameters while respecting same or lower tolerance doses of adjacent normal organs.
Read more
To determine acute and late rectal, urinary and sexual toxicity after this procedure.
To assess the change from baseline in QOL indicators at specific time intervals using validated international questionnaires [International Prostate Symptom Score ( IPSS), International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)] after this treatment.
To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy 36 months after the treatment.
To compare target coverage and relative doses to the rectum and the urethra for the same patient performing a hemigland treatment planning vs Whole gland treatment planning.
STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study will record quality of life parameters in particular in terms of urinary, rectal and sexual function side effects.
INTERVENTION:
- Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not required if already performed)
- Multiparametric MRI within the 3 months prior to registration and at 18 \& 36 months.
- Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy of Iodine125 (I125).
- The quality of life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life
- Postimplant CT Planning day 30 after the implant for quality assurance.
MEASUREMENT OF ENDPOINTS :
Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies at 36 months to assess local control.
- Conditions
- Prostate Cancer
- Being tested
- Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal 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.
Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal BrachytherapyRadiation
A re-staging transperineal template guided mapping prostate biopsy as currently performed at participating institutions. Hemiablative Focal brachytherapy will be performed . The affected half of the prostate will be targeted with the prescription dose and receive 145 Gy of Iodine-125 (I-125). A postimplant dosimetry will be performed 30 days after procedure. The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then 4 weeks, 6 months, 12 months, 20 months, 24 months, 32 months and 36 months after treatment. A second transperineal biopsy will be performed 36 months after the implant.
| Study group | Role | What they receive |
|---|---|---|
| Prostate biopsy,Hemiablative focal Brachytherapy | Experimental | This is a non-randomized, Phase II study examining the efficacy in terms of postimplant dosimetry (primary endpoint) as well as the secondary endpoints of QOL changes, toxicity, local control with post-treatment biopsy outcomes and comparison with historical whole-gland cohorts in men with early stage low volume prostate cancer treated with hemiablative focal brachytherapy Receives: Radiation: Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dosimetric parameters to target and organs at risk in day 30 postimplant dosimetry
Acceptable dosimetric parameters in Day 30 postimplant dosimetry as per brachytherapy guidelines
Measured: 1month to 3 years
Secondary outcomes (7)
Rates of acute and late toxicity assessed by CTCAE v4.0
Treatment related toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: 6months to 10years
Change from baseline in QOL in Genitourinary aspect
This will be assessed using the IPSS questionnaire
Measured: 6 months to 10 years
Change from baseline in QOL in the sexual aspect
This will be assessed using the IIEF questionnaire
Measured: 6 months to 10 years
Change from baseline in QOL in the gastrointestinal aspect
This will be assessed using the EPIC questionnaire
Measured: 6 months to 10 years
Local control as Negative prostate biopsy 36 months after the treatment
Measured: 3 years after treatment
Dosimetric parameters comparison between hemigland treatment vs Whole gland historical cohort
Measured: 6 months to 10 years
Grade of genitourinary and gastrointestinal toxicity assessed by CTCAE v4.0 comparison between hemigland treatment vs Whole gland historical cohort
Measured: 6 months to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2025 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Fernandezots, St George Hospital, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643511
- Sponsor's protocol ID
- STGAF
- Status last verified
- Dec 2015
- First submitted
- 22 Jul 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez Ots A, Bucci J, Chin YS, Malouf D, Howie A, Enari KE. Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol. JMIR Res Protoc. 2016 Jun 13;5(2):e98. doi: 10.2196/resprot.5433.
PubMed 27296781
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02643511
- Acronym / sponsor ID
- STGAF
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 31 Dec 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.
Whole gland LDR brachytherapy has been a well established modality of treating low risk prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to surrounding organs.
AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment for localized prostate cancer demonstrating the feasibility of the delivery of the prescription dose to the half of the prostate in terms of meeting standard dosimetric parameters while respecting same or lower tolerance doses of adjacent normal organs.
To determine acute and late rectal, urinary and sexual toxicity after this procedure.
To assess the change from baseline in QOL indicators at specific time intervals using validated international questionnaires [International Prostate Symptom Score ( IPSS), International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)] after this treatment.
To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy 36 months after the treatment.
To compare target coverage and relative doses to the rectum and the urethra for the same patient performing a hemigland treatment planning vs Whole gland treatment planning.
STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study will record quality of life parameters in particular in terms of urinary, rectal and sexual function side effects.
INTERVENTION:
- Baseline Transperineal Template guided mapping prostate biopsy with >20 cores (not required if already performed)
- Multiparametric MRI within the 3 months prior to registration and at 18 \& 36 months.
- Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy of Iodine125 (I125).
- The quality of life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life
- Postimplant CT Planning day 30 after the implant for quality assurance.
MEASUREMENT OF ENDPOINTS :
Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies at 36 months to assess local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate biopsy,Hemiablative focal Brachytherapy | Experimental | Radiation: Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal BrachytherapyThis is a non-randomized, Phase II study examining the efficacy in terms of postimplant dosimetry (primary endpoint) as well as the secondary endpoints of QOL changes, toxicity, local control with post-treatment biopsy outcomes and comparison with historical whole-gland cohorts in men with early stage low volume prostate cancer treated with hemiablative focal brachytherapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Patients must have histologically proven adenocarcinoma of the prostate.
- 2. Patients must have low or low-tier intermediate prostate cancer
- 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- 6. Men ≥ 65 years of age with a life expectancy estimated to be >10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy.
- 8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days.
Key exclusion criteria (10 listed)
- Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
- Bilateral prostatic disease
- Prior hormonal therapy
- Prior Transurethral resection or middle lobe resection
- Recent IPSS>
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 |
|---|---|---|
| Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal BrachytherapyA re-staging transperineal template guided mapping prostate biopsy as currently performed at participating institutions. Hemiablative Focal brachytherapy will be performed . The affected half of the prostate will be targeted with the prescription dose and receive 145 Gy of Iodine-125 (I-125). A postimplant dosimetry will be performed 30 days after procedure. The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then 4 weeks, 6 months, 12 months, 20 months, 24 months, 32 months and 36 months after treatment. A second transperineal biopsy will be performed 36 months after the implant. | Radiation | Prostate biopsy,Hemiablative focal Brachytherapy |
Primary outcome
Optimal dosimetric parameters to target and organs at risk in day 30 postimplant dosimetry
Time frame: 1month to 3 years
Acceptable dosimetric parameters in Day 30 postimplant dosimetry as per brachytherapy guidelines
7 secondary outcomes
Rates of acute and late toxicity assessed by CTCAE v4.0
Time frame: 6months to 10years
Change from baseline in QOL in Genitourinary aspect
Time frame: 6 months to 10 years
Change from baseline in QOL in the sexual aspect
Time frame: 6 months to 10 years
Change from baseline in QOL in the gastrointestinal aspect
Time frame: 6 months to 10 years
Local control as Negative prostate biopsy 36 months after the treatment
Time frame: 3 years after treatment
Dosimetric parameters comparison between hemigland treatment vs Whole gland historical cohort
Time frame: 6 months to 10 years
Grade of genitourinary and gastrointestinal toxicity assessed by CTCAE v4.0 comparison between hemigland treatment vs Whole gland historical cohort
Time frame: 6 months to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Derived from this study: PubMed 27296781Fernandez Ots A, Bucci J, Chin YS, Malouf D, Howie A, Enari KE. Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol. JMIR Res Protoc. 2016 Jun 13;5(2):e98. doi: 10.2196/resprot.5433.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy in people with Prostate Cancer, run by St George Hospital, Australia at 1 site in Australia.
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 15 inclusion and 10 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 31 Dec 2015. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ana Fernandez, MD (+61291131306, Ana.Fernandezots@SESIAHS.HEALTH.NSW.GOV.AU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal dosimetric parameters to target and organs at risk in day 30 postimplant dosimetry (time frame: 1month to 3 years). 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 NCT02643511, 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 31 Dec 2015.