Stereotactic MRI-Guided Radiation for Localized Prostate Cancer (2SMART)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: SABR

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • SunnyBrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Informed consent obtained
2. Men >18 years
3. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
4. 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2-fraction SABR	Radiation: SABR; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Toxicity	Incidence of acute (≤3 months) complications of interest using Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4)	3months
Late Toxicity	Incidence of late (≥6 months) complications of interest (CTCAE v4)	5 Years
PSA	Proportion of patients with 4 year PSA value < 0.4 ng/ml	5 years
Biochemical Recurrance	5 year biochemical failure rates using the Phoenix definition (nadir PSA + 2 ng/mL)	5 years
Salvage Therapy	Rate of salvage therapy (ADT, surgery or brachytherapy)	5 years
Health Utilities	Health utilities using the EuroQol-5Dimensions (EQ-5D) questionnaire for mobility, usual activities, anxiety/depression, self-care and pain/discomfort.	5 year
Health Utilities	Health utilities using the Patient Oriented Prostate Ultility Scale (PORPUS-U) (0=best quality of life to 1=worst quality of life)	5 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Andrew Loblaw, MD, FRCPC, Sunnybrook Health Sciences Centre, University of Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2018
• Primary Completion (ANTICIPATED): January 23, 2024
• Study Completion (ANTICIPATED): April 23, 2024

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (ACTUAL): July 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 014-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No