Prostatic NeoplasmsNCT01976962
Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
A study testing Stereotactic body RT with MR-guided boost in people with Prostatic Neoplasms, run by CancerCare Manitoba at 1 site in Canada.
Trial summary
To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Stereotactic body RT with MR-guided boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2018to 25 Nov 2021
- Phase
- Interventional
- 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
- Informed consent
- Age >18 years
- Histologically confirmed and centrally reviewed prostate adenocarcinoma based
- PSA within 60 days
- High risk prostate cancer defined as any one of: clinical stage >= T3, Gleason score >= 8, or PSA >=20 and <50 ng/mL.
Who cannot join
- Evidence of lymph node metastasis
- Evidence of distant metastases
- Prior pelvic radiotherapy or brachytherapy
- Previous radical prostatectomy, cryotherapy, or high-frequency ultrasound
- Unable to undergo gold seed insertion
- Immunosuppressive medications
Show all 12Show fewer
- Inflammatory bowel disease
- Unable to undergo MRI
- Previous bilateral orchiectomy
- Previous hormonal therapy including LHRH agonists (leuprolide, goserelin), LHRH antagonists (degarelix), anti-androgens (bicalutamide, flutamide, nilutamide), surgical castration, and estrogens
- Previous finasteride within 14 days.
- Previous dutasteride within 180 days.
Trial locations and contacts
1 site in 1 country.
About this study
To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced radiation therapy techniques to specifically target the tumor and control it with as few radiotherapy clinic visits as possible. This is different than current techniques which treat the whole prostate gland to the same dose, delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to the active tumor while still maintaining adequate radiation dose to the rest of the prostate, the investigators hope to better control prostate cancer and reduce complications to nearby normal tissues.
Read the detailed description
This project combines advances in functional imaging of prostate cancer and hypofractionation through stereotactic body radiotherapy (SBRT), with an aim to improve tumour control and reduce or maintain normal tissue complications. The strategy will make use of the combined effectiveness of several functional imaging approaches to identify the dominant lesion(s) within the prostate. An SBRT treatment plan will be designed which utilizes 5 fractions to treat the entire prostate gland with an additional boost to the dominant lesion. The lower dose to the entire prostate should reduce normal tissue complications but still be effective in treating prostate cancer while the increased dose to the dominant lesion should improve tumour control. The use of only 5 fractions will reduce the number of patient visits, thus reducing overall treatment costs.
- Conditions
- Prostatic Neoplasms
- Being tested
- Stereotactic body RT with MR-guided boost
- Keywords
- Prostatic neoplasms, Radiotherapy, Dose fractionation, Magnetic resonance imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body RT with MR-guided boostRadiation
Patients will receive radiotherapy over 5 fractions delivered once per week over 29 days, with 7.25 Gy per fraction to the whole prostate and 8 Gy per fraction to the dominant intraprostatic lesion. There will be a minimum of 120 hours and maximum of 192 hours between fractions. The entire course of treatment should be completed within no less than 27 days and no longer than 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Prostate stereotactic body RT with MR-guided boost | Experimental | Patients will receive a dose of 36.25 Gy in 5 fractions to the entire prostate and proximal seminal vesicles with an additional boost to the dominant lesion for a total of 40 Gy in 5 fractions. Receives: Radiation: Stereotactic body RT with MR-guided boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life as per EPIC
Expanded Prostate Cancer Index Composite (EPIC) bowel domain
Measured: 6 months
Secondary outcomes (4)
Quality of Life as per EPIC and SF-12
Expanded Prostate Cancer Index Composite (EPIC) questionnaire (other domains) and Medical Outcomes Study Short-Form 12 (SF-12) v2
Measured: Up to 5 years
GU and GI Toxicity
RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities
Measured: Up to 5 years
Biochemical failure
Phoenix defined (nadir PSA + 2 ng/mL) biochemical failure
Measured: 5 years
Pathologic response
Pathologic presence of malignancy on biopsy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study start10 Jan 2018
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Why it stopped: Lack of adequate sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldrich Ong, MD, Principal investigator, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976962
- Sponsor's protocol ID
- MD-13-03
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2013
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01976962
- Acronym / sponsor ID
- MD-13-03
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic neoplasms, Radiotherapy, Dose fractionation, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of adequate sample size.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 6 Nov 2013 (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.
To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced radiation therapy techniques to specifically target the tumor and control it with as few radiotherapy clinic visits as possible. This is different than current techniques which treat the whole prostate gland to the same dose, delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to the active tumor while still maintaining adequate radiation dose to the rest of the prostate, the investigators hope to better control prostate cancer and reduce complications to nearby normal tissues.
Detailed description
This project combines advances in functional imaging of prostate cancer and hypofractionation through stereotactic body radiotherapy (SBRT), with an aim to improve tumour control and reduce or maintain normal tissue complications. The strategy will make use of the combined effectiveness of several functional imaging approaches to identify the dominant lesion(s) within the prostate. An SBRT treatment plan will be designed which utilizes 5 fractions to treat the entire prostate gland with an additional boost to the dominant lesion. The lower dose to the entire prostate should reduce normal tissue complications but still be effective in treating prostate cancer while the increased dose to the dominant lesion should improve tumour control. The use of only 5 fractions will reduce the number of patient visits, thus reducing overall treatment costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate stereotactic body RT with MR-guided boost | Experimental | Radiation: Stereotactic body RT with MR-guided boostPatients will receive a dose of 36.25 Gy in 5 fractions to the entire prostate and proximal seminal vesicles with an additional boost to the dominant lesion for a total of 40 Gy in 5 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Age >18 years
- Histologically confirmed and centrally reviewed prostate adenocarcinoma based
- PSA within 60 days
- High risk prostate cancer defined as any one of: clinical stage >= T3, Gleason score >= 8, or PSA >=20 and <50 ng/mL.
Key exclusion criteria (12 listed)
- Evidence of lymph node metastasis
- Evidence of distant metastases
- Prior pelvic radiotherapy or brachytherapy
- Previous radical prostatectomy, cryotherapy, or high-frequency ultrasound
- Unable to undergo gold seed insertion
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 |
|---|---|---|
| Stereotactic body RT with MR-guided boostPatients will receive radiotherapy over 5 fractions delivered once per week over 29 days, with 7.25 Gy per fraction to the whole prostate and 8 Gy per fraction to the dominant intraprostatic lesion. There will be a minimum of 120 hours and maximum of 192 hours between fractions. The entire course of treatment should be completed within no less than 27 days and no longer than 30 days. | Radiation | Prostate stereotactic body RT with MR-guided boost |
Primary outcome
Quality of Life as per EPIC
Time frame: 6 months
Expanded Prostate Cancer Index Composite (EPIC) bowel domain
4 secondary outcomes
Quality of Life as per EPIC and SF-12
Time frame: Up to 5 years
GU and GI Toxicity
Time frame: Up to 5 years
Biochemical failure
Time frame: 5 years
Pathologic response
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Lack of adequate sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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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.
Aldrich Ong, MD principal investigator
CancerCare Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body RT with MR-guided boost in people with Prostatic Neoplasms, run by CancerCare Manitoba 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 5 inclusion and 12 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 18 Mar 2022. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of adequate sample size.). 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?
Quality of Life as per EPIC (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 18 Mar 2022.