Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer (PRORAD)

Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer

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.

Study Overview

• Status: Withdrawn
• Conditions: Hormone Sensitive Oligometastatic Prostate Cancer
• Intervention / Treatment: Procedure: Radical prostatectomy; Radiation: HDR (19Gy) or SBRT (35-40Gy)

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Radical prostatectomy	Procedure: Radical prostatectomy; Radical prostatectomy
Active Comparator: Arm 2; Radiotherapy	Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients willing to accept their randomization	Patients willing to accept their randomization will be measured as a proportion.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.	7 years
Efficacy	Time to CRPC will be calculated using Kaplan Meier methodology.	7 years
Efficacy	Progression free survival will be calculated using Kaplan Meier methodology.	7 years
Efficacy	Local control will be calculated using Kaplan Meier methodology.	7 years
Efficacy	Distant control will be calculated using Kaplan Meier methodology.	7 years
Efficacy	Overall survival will be calculated using Kaplan Meier methodology.	7 years

Collaborators and Investigators

• Sponsor: Dr. Patrick Cheung
• Investigators: Principal Investigator: Patrick Cheung, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Hypersensitivity; Prostatic Neoplasms
• Other Study ID Numbers: ProRaD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No