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Prostatic NeoplasmsSMARTNCT03961321

Stereotactic MR-guided Adaptive Radiation Therapy for Localized Prostate Cancer

An observational study of Prostatic Neoplasms, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: This prospective study investigates the outcomes of daily online stereotactic MR-guided adaptive radiation therapy (SMART) in patients with localized prostate cancer (cT1c-T3bN0M0). 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 mr guided adaptive radiotherapy
Type of treatment
Surgery or procedure
How many people
104 participants
Where
1 siteNetherlands
Study dates
25 Aug 2016to 17 Apr 2019
How long will I take part?
1 Year
Phase
Observational
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
  • Adult, Older adult

Study population: Patients with localized prostate cancer with a clinical stage T1-3b, with a maximal volume of 90 cc on transrectal ultrasound (TRUS) and no suspicious lymph nodes observed on either a diagnostic MRI or CT scan and no signs of distant metastases on radiological staging are eligible. All patients will be discussed in the multidisciplinary board (MDO) with an urologist, medical oncologist, radiologist, pathologist and a radiation oncologist, all specialized in the treatment of prostate cancer. If the MDO treatment advise comprises external beam radiotherapy, patient eligibility for the study will be assessed, and the treating radiation oncologist will discuss the study with the patient and family.

Who may be able to join

  • Age of 18 years or older
  • WHO performance score 0-2
  • Biopsy proven adenocarcinoma of the prostate
  • Gleason ≥ 6
  • Prostate volume ≤ 90 cc on TRUS
  • T-stage: cT1c-T3b (on MRI and/or endorectal ultrasound)
Show all 13Show fewer
  • All patients should be able to undergo MRI scans
  • No evidence of lymph node or distant metastases on radiological staging
  • The multidisciplinary team advised external beam radiotherapy treatment
  • IPSS (International Prostate Symptoms Score) ≤19
  • Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy
  • The administration of concomitant hormonal therapy is allowed
  • Ability to provide written informed consent.

Who cannot join

  • Previous irradiation in the pelvic region
  • Contra-indications for MRI
  • As no safety data for 0.35 Tesla MRI scanners are available on electronic devices such as pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants, this constitutes an absolute contraindication for this study, even for devices that have been considered safe for MRI scans with higher magnetic field strengths.
  • Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
  • Patients with severe claustrophobia may not be able to tolerate an MRI scan
  • Patients with a hip prosthesis will not be eligible for the MRI scan

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University medical center

    Amsterdam, 1081HV

Other trials in Netherlands

About this study

Official title: SMART (Stereotactic MR-guided Adaptive Radiation Therapy) for Localized Prostate Cancer; a Phase II Study

Rationale: This prospective study investigates the outcomes of daily online stereotactic MR-guided adaptive radiation therapy (SMART) in patients with localized prostate cancer (cT1c-T3bN0M0). Visualization of the prostate, rectum and bladder prior to and during radiation delivery can be used to deliver "gated" treatment (beam-on only when the prostate is in the predetermined position) using small uncertainty margins. The novel MRIdian treatment delivery system (ViewRay, USA), which will be used for this study, allows for the immediate generation of an optimal radiotherapy plan based on the current anatomy of the prostate and surrounding normal organs prior to each fraction. These major advances will (i.e. dosimetrically) allow for an optimisation of normal tissue radiation doses, which should theoretically decrease toxicity to surrounding organs such as the rectum or bladder. Another advantage of this approach is that online MR-based prostate imaging does not rely on implanted gold markers, avoiding an invasive procedure to insert such markers. If proven feasible, this approach could set a new standard of care for patients with localized prostate cancer.

The main goal of this phase II study of SMART for prostate cancer is to evaluate the early and early-delayed toxicity, i.e. within the first year after treatment. An established 5-fraction hypofractionated radiation scheme will be used in this trial.

Read more

Main outcome parameters will include gastro-intestinal, genitourinary and sexual symptoms, which will be monitored at fixed time points using CTCAE criteria. In addition, patient-reported outcomes will be evaluated using EORTC-QOL questionnaires.

Objective: To investigate the early and early-delayed toxicity profile of SMART in patients with localized prostate cancer.

Study design:phase II observational study Study population: 100 consecutive patients with localized prostate cancer (cT1c-T3bN0M0).

Study intervention: Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing of the urethra with a dose of 32.5 Gy in 5 fractions Main study parameters: Early and early-delayed toxicity (CTCAE v. 4.0); (IPSS) and Qol C30 PR25. Secondary endpoint will be the offline evaluation of the dosimetric benefit of SMART by comparing cumulative doses to organs at risk.

Read the detailed description

Rationale: This prospective study investigates the outcomes of daily online stereotactic MR-guided adaptive radiation therapy (SMART) in patients with localized prostate cancer (cT1c-T3bN0M0). Visualization of the prostate, rectum and bladder prior to and during radiation delivery can be used to deliver "gated" treatment (beam-on only when the prostate is in the predetermined position) using small uncertainty margins. The novel MRIdian treatment delivery system (ViewRay, USA), which will be used for this study, allows for the immediate generation of an optimal radiotherapy plan based on the current anatomy of the prostate and surrounding normal organs prior to each fraction. These major advances will (i.e. dosimetrically) allow for an optimisation of normal tissue radiation doses, which should theoretically decrease toxicity to surrounding organs such as the rectum or bladder. Another advantage of this approach is that online MR-based prostate imaging does not rely on implanted gold markers, avoiding an invasive procedure to insert such markers. If proven feasible, this approach could set a new standard of care for patients with localized prostate cancer.

The main goal of this phase II study of SMART for prostate cancer is to evaluate the early and early-delayed toxicity, i.e. within the first year after treatment. An established 5-fraction hypofractionated radiation scheme will be used in this trial. At VUmc, experience with this scheme has been obtained as a result of participation in a recently concluded multicenter randomized phase II trial [METc NL4181402912; 20012/398]. Main outcome parameters will include gastro-intestinal- (GI), genitourinary- (GU) and sexual symptoms, which will be monitored at fixed time points using CTCAE criteria. In addition, patient-reported outcomes will be evaluated using EORTC-QOL questionnaires.

Objective: To investigate the early and early-delayed toxicity profile of SMART in patients with localized prostate cancer.

Study design: A phase II observational study Study population: 100 consecutive patients with localized prostate cancer (cT1c-T3bN0M0).

Study intervention: Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing (SIS) of the urethra with a dose of 32.5 Gy in 5 fractions (6.5 Gy per fraction). This stereotactic radiation scheme was also used in [METc NL4181402912; 20012/398].

Main study parameters: Early and early-delayed toxicity (CTCAE v. 4.0); prostate specific symptom score (IPSS) and Qol (EORTC-QoL C30 \& QLQ Prostate Cancer module (QLQ-PR25)). Secondary endpoint will be the offline evaluation of the dosimetric benefit of SMART by comparing cumulative doses to organs at risk.

Nature, extent of the burden and risks associated with participation, benefit and group relatedness: This novel SMART approach could set a new standard of care for patients with localized prostate cancer by limiting radiation doses to surrounding normal organs and thereby potentially radiation-induced toxicity. Also, implantation of gold markers would become unnecessary using MR-guided "gated" radiotherapy. Disadvantages for patients include the need to be positioned within the MRI bore during radiation delivery, and a prolonged time per treatment fraction (estimated at 30 minutes per fraction), which has to be weighed against the use of a total of only five fractions. As the radiation fractionation scheme that is used in this study has been evaluated in prior trials, no further patient-related risks are anticipated.

Being tested
stereotactic mr guided adaptive radiotherapy
Keywords
SMART, Prostate cancer, SBRT, MRgRT, Toxicity
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 mr guided adaptive radiotherapyRadiation

    Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing (SIS) of the urethra with a dose of 32.5 Gy in 5 fractions (6.5 Gy per fraction).

What is being measured

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

  1. Early gastrointestinal toxicity

    Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Measured: determined at 3 months

  2. Late gastrointestinal toxicity

    Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Measured: determined at 12 months

  3. Early genitourinary toxicity

    Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Measured: determined at 3 months

  4. Late genitourinary toxicity

    Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Measured: determined at 12 months

  5. Early quality of life (QoL)

    EORTC QoL core questionnaire (QLQ-C30)

    Measured: determined at 3 months

  6. Early prostate specific quality of life (QoL)

    EORTC QLQ-PR25

    Measured: determined at 3 months

  7. Late quality of life (QoL)

    EORTC QoL core questionnaire (QLQ-C30)

    Measured: determined at 12 months

  8. Late prostate specific quality of life (QoL)

    EORTC QLQ-PR25

    Measured: determined at 12 months

Timeline

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

  1. First posted23 May 2019
  2. Study start25 Aug 2016
  3. Primary completion17 Apr 2019
  4. Study completion17 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
104 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961321
Sponsor's protocol ID
NL5728902916
Acronym
SMART
Status last verified
May 2019
First submitted
15 May 2019
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tetar SU, Bruynzeel AME, Oei SS, Senan S, Fraikin T, Slotman BJ, Moorselaar RJAV, Lagerwaard FJ. Magnetic Resonance-guided Stereotactic Radiotherapy for Localized Prostate Cancer: Final Results on Patient-reported Outcomes of a Prospective Phase 2 Study. Eur Urol Oncol. 2021 Aug;4(4):628-634. doi: 10.1016/j.euo.2020.05.007. Epub 2020 Jun 12.

    PubMed 32536573

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

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 13 inclusion and 6 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 23 May 2019. 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 Netherlands. 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 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?

Early gastrointestinal toxicity (time frame: determined at 3 months). The study lists 8 primary outcomes in all. 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 NCT03961321, which also lists 1 linked publication.

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 23 May 2019.

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