NCT02563691

Brief Summary

This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

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
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1

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

November 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

7.1 years

First QC Date

July 3, 2015

Last Update Submit

March 6, 2022

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease

    common terminology criteria for adverse events (CTCAE) version 4.0

    cumulative incidence at 2 years

Secondary Outcomes (5)

  • Quality of Life (EORTC QLQ-C30)

    proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months

  • Time to development of castrate resistant prostate cancer

    through study completion, an average of 2 years

  • Radiographic local control of irradiated tumours

    actuarial rate at 2 years

  • Radiographic "distant" control rate

    actuarial rate at 2 years

  • Overall survival

    through study completion, an average of 4 years

Study Arms (1)

Stereotactic radiotherapy

EXPERIMENTAL

Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.

Radiation: stereotactic radiotherapy

Interventions

stereotactic radiotherapyRADIATION

Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken. The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

Also known as: SBRT, SABR
Stereotactic radiotherapy

Eligibility Criteria

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

You may qualify if:

  • Able to provide informed consent.
  • ECOG performance status 0-1.
  • Histologic confirmation of prostate adenocarcinoma.
  • Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
  • ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
  • All sites of disease are amenable to stereotactic radiotherapy.

You may not qualify if:

  • Castrate resistant prostate cancer.
  • Evidence of spinal cord compression.
  • Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
  • Inability to safely treat all sites of visible disease.
  • Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick Cheung, M.D.

    Toronto Sunnybrook Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

July 3, 2015

First Posted

September 30, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations

CA(1)