Stereotactic MR-guided Adaptive Radiation Therapy for Localized Prostate Cancer

NCT03961321 | Completed

• 1 other identifier: NL5728902916
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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.

Conditions

Prostatic Neoplasms

Keywords

SMART; Prostate cancer; SBRT; MRgRT; Toxicity

Outcome Measures

Primary Outcomes (8)

• Early gastrointestinal toxicity

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

  determined at 3 months

• Late gastrointestinal toxicity

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

  determined at 12 months

• Early genitourinary toxicity

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

  determined at 3 months

• Late genitourinary toxicity

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

  determined at 12 months

• Early quality of life (QoL)

  EORTC QoL core questionnaire (QLQ-C30)

  determined at 3 months

• Early prostate specific quality of life (QoL)

  EORTC QLQ-PR25

  determined at 3 months

• Late quality of life (QoL)

  EORTC QoL core questionnaire (QLQ-C30)

  determined at 12 months

• Late prostate specific quality of life (QoL)

  EORTC QLQ-PR25

  determined at 12 months

Interventions

stereotactic mr guided adaptive radiotherapy RADIATION

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).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU University medical center

Amsterdam, 1081HV, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32536573 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Anna Bruynzeel, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 23, 2019
• Study Start: August 25, 2016
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)