2SMART: Stereotactic MRI-Guided Radiation for Localized Prostate Cancer

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03588819

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: SABR	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 23, 2018

Anticipated Primary Completion Date :

Jan 23, 2024

Anticipated Study Completion Date :

Apr 23, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

QOL [5 years]
To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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
Inflammatory bowel disease
Presence of a hip prosthesis
Contraindications to having MRI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrew Loblaw, GU Radiation Oncology Team Lead, Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT03588819

Other Study ID Numbers:

014-2018

First Posted:

Jul 17, 2018

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jun 14, 2022