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Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer

NCT ID: NCT03301701

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2019-05-30

Brief Summary

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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.

Detailed Description

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Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.

Conditions

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Hormone Sensitive Oligometastatic Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Radical prostatectomy

Group Type EXPERIMENTAL

Radical prostatectomy

Intervention Type PROCEDURE

Radical prostatectomy

Arm 2

Radiotherapy

Group Type ACTIVE_COMPARATOR

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

Intervention Type RADIATION

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

Interventions

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Radical prostatectomy

Radical prostatectomy

Intervention Type PROCEDURE

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

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Patrick Cheung

OTHER

Sponsor Role lead

Responsible Party

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Dr. Patrick Cheung

Dr. Patrick Cheung

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patrick Cheung

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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PRORAD

Identifier Type: -

Identifier Source: org_study_id