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Prostate Cancer2SMARTNCT03588819

Stereotactic MRI-Guided Radiation for Localized Prostate Cancer

A study testing SABR in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This single arm, prospective study will determine the prostate-specific quality of life (QOL) of patients undergoing undergoing a 2 fraction MRI-guided stereotactic ablative body radiation (SABR) protocol. 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?
SABR
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
23 Apr 2018to 23 Apr 2024
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 obtained
  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • Favorable risk prostate cancer, defined as clinical stage T1-2c, Gleason Sum less than or equal to 7, and PSA less than or equal to 20 ng/mL (patients can have only one of T2c, Gleason Sum 7 and PSA 10-20 ng/ml)

Who cannot join

  • Androgen deprivation therapy (LHRH-agonists or antiandrogens) > 6 mo
  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Large prostate (>90cm3) on imaging
  • Immunosuppressive medications
Show all 9Show fewer
  • Inflammatory bowel disease
  • Presence of a hip prosthesis
  • Contraindications to having MRI

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Two Stereotactic MRI-Guided Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer (2SMART)

This single arm, prospective study will determine the prostate-specific quality of life (QOL) of patients undergoing undergoing a 2 fraction MRI-guided stereotactic ablative body radiation (SABR) protocol. We propose prescribing a prostate dose of 26 Gy in 2 fractions and a dose of up to 32 Gy to the dominant intraprostatic lesion (DIL) in 2 fractions over one week.

Read the detailed description

Stereotactic Ablative Body Radiation Two weekly fractions of:

13 Gy to whole prostate +/- seminal vesicles AND Up to 16 Gy simultaneous boost to dominant MRI nodule

Treatment Delivery and Quality Assurance Treatment will be delivered on treatment units equipped with with volumetric arc therapy and hexapod couches. Only photons with megavoltage energies of 6 MV will be used. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. Imaging after each fraction of radiation will be performed and the shifts in prostate positioning (as measured by displacement of gold seed fiducials) will be measured and recorded. Also, the total treatment time for each fraction of radiotherapy will be recorded.

Patient Assessments / Follow-up Time zero will be the start of radiotherapy. Baseline and follow-up parameters are as listed in Appendix A. Baseline rectal and urinary function will be recorded. Acute toxicities will be assessed at weeks 1, 4, and 13 and late toxicities will be assessed at month 6 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, version 4.0. Bloodwork (PSA and testosterone), will be performed at months 3, 6 and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 13, month 6 and every 6 months until year 5.

Conditions
Prostate Cancer
Being tested
SABR
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SABRRadiation

    26 Gy in 2 fractions to the prostate and DIL dose of up to 32 Gy in 2 fractions of MR-guided SABR delivered 1 week apart

Study groups in NCT03588819
Study groupRoleWhat they receive
2-fraction SABRExperimentalNot described
Receives: Radiation: SABR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QOL

    To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC)

    Measured: 5 years

Secondary outcomes (7)

  1. Acute Toxicity

    Incidence of acute (≤3 months) complications of interest using Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4)

    Measured: 3months

  2. Late Toxicity

    Incidence of late (≥6 months) complications of interest (CTCAE v4)

    Measured: 5 Years

  3. PSA

    Proportion of patients with 4 year PSA value < 0.4 ng/ml

    Measured: 5 years

  4. Biochemical Recurrance

    5 year biochemical failure rates using the Phoenix definition (nadir PSA + 2 ng/mL)

    Measured: 5 years

  5. Salvage Therapy

    Rate of salvage therapy (ADT, surgery or brachytherapy)

    Measured: 5 years

  6. Health Utilities

    Health utilities using the EuroQol-5Dimensions (EQ-5D) questionnaire for mobility, usual activities, anxiety/depression, self-care and pain/discomfort.

    Measured: 5 year

  7. Health Utilities

    Health utilities using the Patient Oriented Prostate Ultility Scale (PORPUS-U) (0=best quality of life to 1=worst quality of life)

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2018
  2. Study start23 Apr 2018
  3. Primary completion23 Jan 2024 (estimated)
  4. Study completion23 Apr 2024 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03588819
Sponsor's protocol ID
014-2018
Acronym
2SMART
Status last verified
Jun 2022
First submitted
2 Jul 2018
Last updated
14 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ong WL, Davidson M, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. Dosimetric correlates of toxicities and quality of life following two-fraction stereotactic ablative radiotherapy (SABR) for prostate cancer. Radiother Oncol. 2023 Nov;188:109864. doi: 10.1016/j.radonc.2023.109864. Epub 2023 Aug 22.

    PubMed 37619656

  • Ong WL, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Davidson M, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. To Boost or Not to Boost: Pooled Analyses From 2-Fraction SABR Trials for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1153-1162. doi: 10.1016/j.ijrobp.2023.06.250. Epub 2023 Jul 5.

    PubMed 37419394

Questions about this trial

What is this clinical trial studying?

A study testing SABR 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 4 inclusion and 9 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 14 Jun 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?

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?

QOL (time frame: 5 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 NCT03588819, which also lists 2 linked publications.

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 14 Jun 2022.

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