Carcinoma ProstatePhase 1/2DelightNCT03323879
Combined LDR Boost and HDR Whole Gland
A Phase 1/2 study testing LDR/HDR in people with Carcinoma Prostate, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Carcinoma Prostate
- What is being tested?
- LDR/HDR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2017to 1 Jul 2020
- Phase
- Phase 1/2
- 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
- Confirmed Adenocarcinoma of the prostate
- Single PIRADS 4 or 5 lesion on multiparametric MRI
- T1c-T2b on rectal exam
- Gleason 3+3 and PSA < 20ng/mL
- Gleason 3+4 and PSA <10ng/mL
- Less than 50% of the cores positive in an untargeted prostate biopsy.
- Prostate volume < 60 cc
Who cannot join
- Incapable or ineligible for MRI imaging
- Previous trans-urethral resection of prostate (TURP)
- Previous or current use of androgen deprivation
- Baseline International Prostate Symptom Score (IPSS) > 15
- Evidence of distant or nodal metastasis
- Disease that contraindicates treatment with radiation (e.g connective tissue disease)
- Unsuitable for anesthesia due to comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis
This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.
Read the detailed description
Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal brachytherapy to the DIL using iodine-125, while at the same time have single 19 Gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (HDR). The LDR boost dose will start at 50 Gy, and increase DIL dose in sequential cohorts of patients up until a dose of 80 Gy. Up to 20 patients will be included. Primary endpoint is toxicity at 3 months.
- Conditions
- Carcinoma Prostate
- Being tested
- LDR/HDR
- Keywords
- brachytherapy, LDR, HDR, monotherapy, focal
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDR/HDRRadiation
Focal LDR to dominant lesion with whole gland 19 Gy HDR
| Study group | Role | What they receive |
|---|---|---|
| LDR/HDR | Experimental | MRI planned LDR boost to DIL with concurrent whole gland 19 Gy HDR. LDR dose will be sequentially escalated from 50 Gy to 80 Gy Receives: Radiation: LDR/HDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0
Measured: At 3 months
Secondary outcomes (3)
Late urinary and rectal toxicity using NCI CTCAE v4.0
Cumulative incidence of urinary and rectal toxicity beyond 3 months using NCI CTCAE v4.0.
Measured: 3-monthly for first year, then 6-monthly until Year 5
Health related quality of life (HRQOL) changes
Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)
Measured: 3 monthly for first year, then annually year 1-5
Disease Free Survival
biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)
Measured: will be reported at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start30 Oct 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma ProstateStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sequential dose escalation design
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323879
- Sponsor's protocol ID
- DELIGHT
- Acronym
- Delight
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis
- ClinicalTrials.gov ID
- NCT03323879
- Acronym / sponsor ID
- Delight / DELIGHT
- Conditions
- Carcinoma Prostate
- Keywords
- brachytherapy, LDR, HDR, monotherapy, focal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 27 Oct 2017 (actual)
- 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.
This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.
Detailed description
Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal brachytherapy to the DIL using iodine-125, while at the same time have single 19 Gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (HDR). The LDR boost dose will start at 50 Gy, and increase DIL dose in sequential cohorts of patients up until a dose of 80 Gy. Up to 20 patients will be included. Primary endpoint is toxicity at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential dose escalation design
| Arm | Type | Receives |
|---|---|---|
| LDR/HDR | Experimental | Radiation: LDR/HDRMRI planned LDR boost to DIL with concurrent whole gland 19 Gy HDR. LDR dose will be sequentially escalated from 50 Gy to 80 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed Adenocarcinoma of the prostate
- Single PIRADS 4 or 5 lesion on multiparametric MRI
- T1c-T2b on rectal exam
- Gleason 3+3 and PSA < 20ng/mL
- Gleason 3+4 and PSA <10ng/mL
Key exclusion criteria (7 listed)
- Incapable or ineligible for MRI imaging
- Previous trans-urethral resection of prostate (TURP)
- Previous or current use of androgen deprivation
- Baseline International Prostate Symptom Score (IPSS) > 15
- Evidence of distant or nodal metastasis
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 |
|---|---|---|
| LDR/HDRFocal LDR to dominant lesion with whole gland 19 Gy HDR | Radiation | LDR/HDR |
Primary outcome
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
Time frame: At 3 months
Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0
3 secondary outcomes
Late urinary and rectal toxicity using NCI CTCAE v4.0
Time frame: 3-monthly for first year, then 6-monthly until Year 5
Health related quality of life (HRQOL) changes
Time frame: 3 monthly for first year, then annually year 1-5
Disease Free Survival
Time frame: will be reported at 5 years
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 27 Apr 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.
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?
A Phase 1/2 study testing LDR/HDR in people with Carcinoma Prostate, run by Sunnybrook Health Sciences Centre 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 7 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: stopped early, as of the sponsor's last update on 27 Apr 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 combined 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.
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 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?
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0 (time frame: At 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 27 Apr 2021.