Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619069
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: SBRT Drug: Hormone therapy Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1: Standard of Care
Intermittent Hormone treatment (minimum of 8 months)
Drug: Hormone therapy
Intermittent Hormone Therapy per physician discretion (Min. 8 months)

Experimental: Arm 2: SBRT to mets

Intermittent Hormone treatment (minimum of 8 months)

+ SBRT to all sites of metastatic disease

Radiation: SBRT
SBRT to all sites of metastatic disease as seen on PSMA PET scan

Drug: Hormone therapy
Intermittent Hormone Therapy per physician discretion (Min. 8 months)




Primary Outcome Measures :
  1. Proportion of eligible patients who enroll onto the study [ Time Frame: Through accrual completion, approx 2 years ]
    The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial


Secondary Outcome Measures :
  1. Side Effects and Effectiveness [ Time Frame: Through study completion, approx 5 years ]
    An important secondary purpose is to measure the side effects and effectiveness of adding stereotactic radiotherapy to all sites of disease to intermittent hormone therapy compared to intermittent hormone therapy alone, using CTCAE v.5



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer Patients only. Males only.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years.
  2. Able to provide informed consent.
  3. Histologic diagnosis of prostate adenocarcinoma.
  4. ECOG performance status 0-1.
  5. Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
  6. Up to a maximum of 3 PSMA avid areas of metastatic disease.
  7. For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be > 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
  8. All sites of disease are amenable to and can be safely treated with SBRT.

Exclusion Criteria:

  1. Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
  2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
  3. Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
  4. Castrate resistant prostate cancer.
  5. Evidence of spinal cord compression.

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): NCT04619069


Contacts
Layout table for location contacts
Contact: Patrick Cheung 4164805000 patrick.cheung@sunnybrook.ca

Locations
Layout table for location information
Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Patrick Cheung    4164805000    patrick.cheung@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Layout table for additonal information
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04619069    
Other Study ID Numbers: iSTOP
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs