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SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer (SHARP)

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ClinicalTrials.gov Identifier: NCT04861415
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Gerard Morton, Sunnybrook Health Sciences Centre

Brief Summary:
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Sterotactic Body Radiotherapy Radiation: Conventionally Fractionated Radiation Not Applicable

Detailed Description:
Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
Actual Study Start Date : December 23, 2020
Estimated Primary Completion Date : December 23, 2022
Estimated Study Completion Date : December 23, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Conventional Fractionated Radiation
  • Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle
  • Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes
Radiation: Conventionally Fractionated Radiation
External beam radiation therapy treatment

Experimental: Stereotactic Body Radiotherapy
  • Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle
  • Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes
Radiation: Sterotactic Body Radiotherapy
Hypofractionated stereotactic radiation treatment.
Other Name: SBRT




Primary Outcome Measures :
  1. Treatment Feasibility [ Time Frame: 18mo - 2 years ]
    The proportion of patients accepting of being randomized divided by the number of patients approached for the study.


Secondary Outcome Measures :
  1. QOL [ Time Frame: 7 years ]
    Urinary, bowel and sexual health-related quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC) domains over the study period. Each domain is normalized from 0 to 100, with a higher score indicating better outcome.

  2. Treatment Toxicity [ Time Frame: 7 years ]
    Proportion of patients with urinary, bowel and sexual Grade 2 and 3 toxicity measured by CTCAE v5.0 throughout the study period.

  3. Cumulative biochemical failure [ Time Frame: 7 years ]
    Defined as the time of enrolment to biochemical failure (based on the Phoenix definition, PSA nadir plus 2)

  4. Overall Survival [ Time Frame: 7 years ]
    Defined as time of enrollment to death from any cause

  5. Cancer Free Survival [ Time Frame: 7 years ]
    Defined as time of enrolment to death attributed to prostate cancer

  6. Metastasis Free Survival [ Time Frame: 7 years ]
    Defined as time of enrolment to development of metastasis or death from any cause

  7. Freedom From Local Failure [ Time Frame: 7 years ]
    Defined as time of enrolment to first local recurrence

  8. Freedom From Regional Failure [ Time Frame: 7 years ]
    Defined as time of enrolment to first regional recurrence

  9. ADT Free Survival [ Time Frame: 7 Years ]
    Defined as time of enrolment to salvage ADT use or death from any cause

  10. PSA nadir [ Time Frame: 6 years ]
    PSA nadir at 4-years post treatment



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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:

  • Age 18 or older
  • Informed consent for treatment and study participation completed
  • Pathologically proven diagnosis of prostate adenocarcinoma
  • ECOG Performance Status 0-2
  • No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy

Exclusion Criteria:

  • Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
  • Plan for adjuvant chemotherapy post-radiotherapy
  • Serious medical comorbidities or other contraindications to HDR brachytherapy
  • Presence of inflammatory bowel disease
  • Presence of connective tissue disorder seen as a contraindication to radiotherapy
  • Medically unfit for general/spinal anesthesia
  • Unable or unwilling to complete questionnaires

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): NCT04861415


Contacts
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Contact: Gerard Morton, MD 416-480-6100 ext 6165 gerard.morton@sunnybrook.ca
Contact: Merrylee McGuffin 416-480-6100 ext 85454 Merrylee.Mcguffin@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gerard Morton, MD, FRCPC    416-480-6100 ext 6165      
Contact: Merrylee McGuffin, MSc, MRT(T)    416-480-6100 ext 85454    Merrylee.Mcguffin@sunnybrook.ca   
Principal Investigator: Mark Corkum         
Sponsors and Collaborators
Dr. Gerard Morton
Investigators
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Principal Investigator: Gerard Morton Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Gerard Morton, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04861415    
Other Study ID Numbers: 2734
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases