Prostate CancerPhase 2/3EARTHNCT04654338
2 Ablative RadioTherapy Treatments for Prostate Cancer
A Phase 2/3 study testing SABR + HDR in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SABR + HDR
- 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
- 29 Jul 2020to 29 Jul 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Favorable risk disease defined as either:
- Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
- Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
- Prostate volume < 60 cc as determined by US, CT or MRI
- Ability to undergo MR imaging
- Provide written informed consent
Who cannot join
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous transurethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
- Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Significant medical co-morbidity rendering patient unsuitable for general anaesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Andrew Loblaw, MD, FRCPC, 416-480-4806, Andrew.Loblaw@sunnybrook.ca
Merrylee McGuffin, MSc, MRT(T), 416-480-6100 ext. 85454, Merrylee.Mcguffin@sunnybrook.ca
About this study
Official title: Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.
Read the detailed description
Pre-Treatment:
Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Centre (OCC) biobanking protocol)
Stereotactic Ablative Body Radiation (SABR):
13.5Gy x 1 to whole prostate + 1cm seminal vesicles 2 weeks post-planning, treatment will be delivered as per standard treatment protocols on SABR-compatible linear accelerator with a six-degree of freedom couch. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. All dosimetric parameters will be recorded.
Inter-treatment (approx 1 week post-SABR):
Planning mpMRI and TRUS imaging for HDR Biobanking of urine and blood (as per REB#079-2006 OCC biobanking protocol)
HDR brachytherapy:
13.5 Gy x 1 to the prostate, <20 Gy to DIL Approx 2-3 weeks post-SABR, the HDR dose prescription of 13.5 Gy to the whole gland and <20 Gy to MRI visible lesion will be delivered in one fraction, assuming that dose constraints to critical organs can be met. All dosimetric parameters will be recorded
Patient Assessments / Follow-up Time zero will be the date of SABR treatment. Baseline rectal, urinary and sexual function will be recorded prior to treatment. Acute toxicities will be assessed at 6, 12 and 24 weeks and late toxicities will be assessed at month 9, 24 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, V 4.0. Bloodwork (PSA and testosterone) and International Prostate Symptom Score (IPSS) evaluations will be performed at baseline week 6, month 3, 6, 9 and 24, and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC), EQ-5D and PORPUS questionnaires will be obtained at baseline, month 3, 6, 9 and 24 and every 6 months until year 5. Post-treatment biobanking will be done at 13 and 52 weeks (as per REB#079-2006 OCC biobanking protocol)
- Conditions
- Prostate Cancer
- Being tested
- SABR + HDR
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABR + HDRRadiation
One SABR treatment + one HDR brachytherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Radiation: SABR + HDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicities
Acute GU and GI toxicities according to the NCI CTCAE v4.0
Measured: 6 months
Secondary outcomes (3)
Late Toxicities
Late GU and GI toxicities according to the NCI CTCAE v4.0
Measured: 5 years
QOL
Quality of life changes utilizing the Expanded Prostate Index Composite (EPIC)
Measured: 5 years
PSA
Biochemical failure and PSA kinetics using PSA response rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start29 Jul 2020
- Primary completion29 Jan 2024 (estimated)
- Study completion29 Jul 2028 (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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Loblaw, Sunnybrook Health Sciences Centre
- Investigators
- Andrew Loblaw, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654338
- Sponsor's protocol ID
- 3592
- Acronym
- EARTH
- Status last verified
- Jun 2022
- First submitted
- 29 Nov 2020
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
- ClinicalTrials.gov ID
- NCT04654338
- Acronym / sponsor ID
- EARTH / 3592
- Conditions
- Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 29 Jan 2024 (estimated)
- Study completion
- 29 Jul 2028 (estimated)
- First posted
- 4 Dec 2020 (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.
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.
Detailed description
Pre-Treatment:
Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Centre (OCC) biobanking protocol)
Stereotactic Ablative Body Radiation (SABR):
13.5Gy x 1 to whole prostate + 1cm seminal vesicles 2 weeks post-planning, treatment will be delivered as per standard treatment protocols on SABR-compatible linear accelerator with a six-degree of freedom couch. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. All dosimetric parameters will be recorded.
Inter-treatment (approx 1 week post-SABR):
Planning mpMRI and TRUS imaging for HDR Biobanking of urine and blood (as per REB#079-2006 OCC biobanking protocol)
HDR brachytherapy:
13.5 Gy x 1 to the prostate, <20 Gy to DIL Approx 2-3 weeks post-SABR, the HDR dose prescription of 13.5 Gy to the whole gland and <20 Gy to MRI visible lesion will be delivered in one fraction, assuming that dose constraints to critical organs can be met. All dosimetric parameters will be recorded
Patient Assessments / Follow-up Time zero will be the date of SABR treatment. Baseline rectal, urinary and sexual function will be recorded prior to treatment. Acute toxicities will be assessed at 6, 12 and 24 weeks and late toxicities will be assessed at month 9, 24 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, V 4.0. Bloodwork (PSA and testosterone) and International Prostate Symptom Score (IPSS) evaluations will be performed at baseline week 6, month 3, 6, 9 and 24, and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC), EQ-5D and PORPUS questionnaires will be obtained at baseline, month 3, 6, 9 and 24 and every 6 months until year 5. Post-treatment biobanking will be done at 13 and 52 weeks (as per REB#079-2006 OCC biobanking protocol)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Radiation: SABR + HDR |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Favorable risk disease defined as either:
- Prostate volume < 60 cc as determined by US, CT or MRI
- Ability to undergo MR imaging
- Provide written informed consent
Key exclusion criteria (7 listed)
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous transurethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
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 |
|---|---|---|
| SABR + HDROne SABR treatment + one HDR brachytherapy treatment | Radiation | Intervention Arm |
Primary outcome
Acute Toxicities
Time frame: 6 months
Acute GU and GI toxicities according to the NCI CTCAE v4.0
3 secondary outcomes
Late Toxicities
Time frame: 5 years
QOL
Time frame: 5 years
PSA
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Andrew Loblaw, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SABR + HDR in people with Prostate Cancer, 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: looking for participants now, as of the sponsor's last update on 27 Jun 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merrylee McGuffin, MSc (416-480-6100 ext. 85454, Merrylee.Mcguffin@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Toxicities (time frame: 6 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 Jun 2023.