NCT03588819

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

5.8 years

First QC Date

July 2, 2018

Last Update Submit

June 12, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • QOL

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

    5 years

Secondary Outcomes (7)

  • Acute Toxicity

    3months

  • Late Toxicity

    5 Years

  • PSA

    5 years

  • Biochemical Recurrance

    5 years

  • Salvage Therapy

    5 years

  • +2 more secondary outcomes

Study Arms (1)

2-fraction SABR

EXPERIMENTAL
Radiation: SABR

Interventions

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

2-fraction SABR

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37419394DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Loblaw, MD, FRCPC

    Sunnybrook Health Sciences Centre, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GU Radiation Oncology Team Lead

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 17, 2018

Study Start

April 23, 2018

Primary Completion

January 23, 2024

Study Completion

April 23, 2024

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)