Prostate CancerPhase 2HDRvsLDRNCT02628041
HDR Brachytherapy vs. LDR Brachytherapy Monotherapy in Localized Prostate Cancer
A Phase 2 study testing Permanent Iodine-125 seed implant and High-Dose-rate Prostate Brachytherapy in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Permanent Iodine-125 seed implant and High-Dose-rate Prostate Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Feb 2021
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months.
- Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months).
- Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL.
- Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores.
- Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.
- No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
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- Eastern Cooperative Oncology Group status 0-1
- No hormonal therapy is accepted.
- Prostate volume by Trans-rectal Ultrasound (TRUS) ≤ 60 cc.
- Internation Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed)
Who cannot join
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Prior or current bleeding diathesis
- Previous androgen deprivation therapy within 6 months of the registration.
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.
- Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
- Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
- Gleason score 7 (4+3), clinical stage≥ T3a, PSA > 20 and > 60% of positive cores.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years.
HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress.
The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.
Read the detailed description
Primary Endpoint:
- To evaluate the differences in QOL in the urinary domain between patients treated with Low-Dose Rate Brachytherapy (LDRB) and High-Dose Rate Brachytherapy (HDRB) at 3 months.
Secondary Endpoints:
- To compare LDRB vs. HDR as related to the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
- To evaluate differences in urinary function using the IPSS which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
- To report acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
- To report the dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
- To assess local control by performing prostate rebiopsy after radiotherapy at 36 months to assess treatment outcome.
- The absolute Prostate Specific Antigen ( PSA) nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
- Conditions
- Prostate Cancer
- Being tested
- Permanent Iodine-125 seed implant, High-Dose-rate Prostate Brachytherapy
- Keywords
- High-Dose-Rate Brachytherapy, HDR Monotherapy, LDR monotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Iodine-125 seed implantRadiation
Permanent Iodine seed implant is performed under general or epidural anesthesia with the patient is positioned in the lithotomy position.
A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, the prostates is scanned and the dosimetry is generated. Catheters are inserted in the prostate and the seeds are injected using the Nucletron automatic after loader according to the dosimetry plan.
The catheters are removed at the end of the procedure.
High-Dose-rate Prostate BrachytherapyRadiation
Also called HDR implant
High-Dose-Rate Prostate brachytherapy is performed under general or epidural anesthesia, the patient is positioned in the lithotomy position.
A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, catheters are inserted in the prostate to assure adequate coverage. The patient is returned in dorsal decubitus and a CT scan or Ultrasound scan is performed. A inverse-planning dosimetry plan is generated to deliver 19 Gy to the target volume. The patient is treated and then the implant is removed and anesthesia is reversed.
| Study group | Role | What they receive |
|---|---|---|
| Permanent Iodine-125 seed implant | Active comparator | Prostate brachytherapy using Iodine-125 seed implant to a prescription dose of 144 Gy delivered to the Target volume defined as Clinical Target volume (CTV)+ 0-3 mm margin. Receives: Radiation: Permanent Iodine-125 seed implant |
| High-dose-Rate Prostate brachytherapy | Experimental | Prostate brachytherapy implant using Iridium-192 to a prescription dose of 19 Gy delivered to the CTV in one fraction. Greater than 95% coverage of the CTV with the prescription dose is considered per protocol, 90-95% coverage is considered a minor deviation and, < 90% coverage is considered a major deviation.
Attempts should be made to achieve these other dosimetric values:
* D90: 105-115%
* V150 ≤ 35%
* V200 ≤ 12% Receives: Radiation: High-Dose-rate Prostate Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life differences at 3 months using the Expanded Prostate Cancer Index Composite in the urinary domain.
Measured: 3 months
Secondary outcomes (6)
Quality of life differences using the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
Measured: 24 months
Differences in urinary function using the International Prostate Symptom Score which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
Measured: 24 months
Acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
Measured: 24 months
The dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
Measured: 1month
Local control by performing transrectal-ultrasound guided 12-core prostate rebiopsy at 36 months to assess treatment outcome.
Measured: 36 months
The absolute PSA nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
Patients will undergo a prostate biopsy at 36 months and the pathology will be reviewed by a Genito-urinary pathology expert and classified in 3 categories: negative (no evidence of cancer), positive ( persistence of cancer cells) and undetermined.
Measured: every 6 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionFeb 2021
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Lara Hathout, CHU de Quebec-Universite Laval
- Investigators
- Lara Hathout, MD, FRCPC, Principal investigator, Centre Hospitalier Universitaire du CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628041
- Sponsor's protocol ID
- MP-20-2016-2570
- Acronym
- HDRvsLDR
- Status last verified
- Feb 2021
- First submitted
- 7 Dec 2015
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02628041
- Acronym / sponsor ID
- HDRvsLDR / MP-20-2016-2570
- Conditions
- Prostate Cancer
- Keywords
- High-Dose-Rate Brachytherapy, HDR Monotherapy, LDR monotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Université de Montréal, Sunnybrook Health Sciences Centre
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 11 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.
High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years.
HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress.
The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.
Detailed description
Primary Endpoint:
- To evaluate the differences in QOL in the urinary domain between patients treated with Low-Dose Rate Brachytherapy (LDRB) and High-Dose Rate Brachytherapy (HDRB) at 3 months.
Secondary Endpoints:
- To compare LDRB vs. HDR as related to the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
- To evaluate differences in urinary function using the IPSS which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
- To report acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
- To report the dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
- To assess local control by performing prostate rebiopsy after radiotherapy at 36 months to assess treatment outcome.
- The absolute Prostate Specific Antigen ( PSA) nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permanent Iodine-125 seed implant | Active comparator | Radiation: Permanent Iodine-125 seed implantProstate brachytherapy using Iodine-125 seed implant to a prescription dose of 144 Gy delivered to the Target volume defined as Clinical Target volume (CTV)+ 0-3 mm margin. |
| High-dose-Rate Prostate brachytherapy | Experimental | Radiation: High-Dose-rate Prostate BrachytherapyProstate brachytherapy implant using Iridium-192 to a prescription dose of 19 Gy delivered to the CTV in one fraction. Greater than 95% coverage of the CTV with the prescription dose is considered per protocol, 90-95% coverage is considered a minor deviation and, < 90% coverage is considered a major deviation. Attempts should be made to achieve these other dosimetric values: * D90: 105-115% * V150 ≤ 35% * V200 ≤ 12% |
Who may qualify
- Ages
- 18 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 diagnosed within the last 9 months.
- Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months).
- Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL.
- Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores.
- Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.
Key exclusion criteria (7 listed)
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Prior or current bleeding diathesis
- Previous androgen deprivation therapy within 6 months of the registration.
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.
- Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
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 |
|---|---|---|
| Permanent Iodine-125 seed implantPermanent Iodine seed implant is performed under general or epidural anesthesia with the patient is positioned in the lithotomy position. A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, the prostates is scanned and the dosimetry is generated. Catheters are inserted in the prostate and the seeds are injected using the Nucletron automatic after loader according to the dosimetry plan. The catheters are removed at the end of the procedure. | Radiation | Permanent Iodine-125 seed implant |
| High-Dose-rate Prostate BrachytherapyAlso: HDR implantHigh-Dose-Rate Prostate brachytherapy is performed under general or epidural anesthesia, the patient is positioned in the lithotomy position. A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, catheters are inserted in the prostate to assure adequate coverage. The patient is returned in dorsal decubitus and a CT scan or Ultrasound scan is performed. A inverse-planning dosimetry plan is generated to deliver 19 Gy to the target volume. The patient is treated and then the implant is removed and anesthesia is reversed. | Radiation | High-dose-Rate Prostate brachytherapy |
Primary outcome
Quality of Life differences at 3 months using the Expanded Prostate Cancer Index Composite in the urinary domain.
Time frame: 3 months
6 secondary outcomes
Quality of life differences using the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
Time frame: 24 months
Differences in urinary function using the International Prostate Symptom Score which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
Time frame: 24 months
Acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
Time frame: 24 months
The dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
Time frame: 1month
Local control by performing transrectal-ultrasound guided 12-core prostate rebiopsy at 36 months to assess treatment outcome.
Time frame: 36 months
The absolute PSA nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
Time frame: every 6 months up to 5 years
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 9 Feb 2021.
- 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.
Lara Hathout, MD, FRCPC principal investigator
Centre Hospitalier Universitaire du CHU de Québec
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 Permanent Iodine-125 seed implant and High-Dose-rate Prostate Brachytherapy in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 7 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 9 Feb 2021. 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 Canada. 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?
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?
Quality of Life differences at 3 months using the Expanded Prostate Cancer Index Composite in the urinary domain. (time frame: 3 months). 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 9 Feb 2021.