NCT03301701

Brief Summary

Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

January 11, 2017

Last Update Submit

November 26, 2020

Conditions

Hormone Sensitive Oligometastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Patients willing to accept their randomization

    Patients willing to accept their randomization will be measured as a proportion.

    2 years

Secondary Outcomes (6)

  • Toxicity

    7 years

  • Efficacy

    7 years

  • Efficacy

    7 years

  • Efficacy

    7 years

  • Efficacy

    7 years

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Radical prostatectomy

Procedure: Radical prostatectomy

Arm 2

ACTIVE COMPARATOR

Radiotherapy

Radiation: HDR (19Gy) or SBRT (35-40Gy)

Interventions

Radical prostatectomyPROCEDURE

Radical prostatectomy

Arm 1
HDR (19Gy) or SBRT (35-40Gy)RADIATION

Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Able to provide informed consent.
  • Histologic confirmation of prostate adenocarcinoma.
  • Stage IV disease with ≤ 5 metastases outside of the pelvis.
  • ≤ 3 metastases in any one organ system.
  • ECOG performance 0-1.
  • All metastatic tumours amenable to SBRT.
  • Patient eligible for either RP or RT to the prostate.

You may not qualify if:

  • Castration resistant prostate cancer.
  • Previous RP or RT to prostate.
  • Inability to treat all metastases with SBRT.
  • Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Study Officials

  • Patrick Cheung

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Patrick Cheung

Study Record Dates

First Submitted

January 11, 2017

First Posted

October 4, 2017

Study Start

September 22, 2017

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)