Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer

Hormone Sensitive Oligometastatic Prostate Cancer Clinical Trial

— PRORAD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03301701
• Other study ID #: PRORAD
• Status: Withdrawn
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: November 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hormone Sensitive Oligometastatic Prostate Cancer
• Hypersensitivity
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy
Radical prostatectomy

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Patrick Cheung

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients willing to accept their randomization	Patients willing to accept their randomization will be measured as a proportion.	2 years
Secondary	Toxicity	Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.	7 years
Secondary	Efficacy	Time to CRPC will be calculated using Kaplan Meier methodology.	7 years
Secondary	Efficacy	Progression free survival will be calculated using Kaplan Meier methodology.	7 years
Secondary	Efficacy	Local control will be calculated using Kaplan Meier methodology.	7 years
Secondary	Efficacy	Distant control will be calculated using Kaplan Meier methodology.	7 years
Secondary	Efficacy	Overall survival will be calculated using Kaplan Meier methodology.	7 years