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

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ClinicalTrials.gov Identifier: NCT03301701
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Cheung, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Hormone Sensitive Oligometastatic Prostate Cancer Procedure: Radical prostatectomy Radiation: HDR (19Gy) or SBRT (35-40Gy) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Patients willing to accept their randomization [ Time Frame: 2 years ]
    Patients willing to accept their randomization will be measured as a proportion.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 7 years ]
    Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.

  2. Efficacy [ Time Frame: 7 years ]
    Time to CRPC will be calculated using Kaplan Meier methodology.

  3. Efficacy [ Time Frame: 7 years ]
    Progression free survival will be calculated using Kaplan Meier methodology.

  4. Efficacy [ Time Frame: 7 years ]
    Local control will be calculated using Kaplan Meier methodology.

  5. Efficacy [ Time Frame: 7 years ]
    Distant control will be calculated using Kaplan Meier methodology.

  6. Efficacy [ Time Frame: 7 years ]
    Overall survival will be calculated using Kaplan Meier methodology.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301701


Contacts
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Contact: Merrylee McGuffin 416-480-5000 ext 6104 merrylee.mcguffin@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Merrylee McGuffin    416-480-5000 ext 6104    merrylee.mcguffin@sunnybrook.ca   
Sponsors and Collaborators
Dr. Patrick Cheung
Investigators
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Principal Investigator: Patrick Cheung Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03301701     History of Changes
Other Study ID Numbers: PRORAD
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs