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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2027
  • participants needed
    55
  • sponsor
    Dr. Gerard Morton
Updated on 10 May 2022

Summary

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

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

Details
Condition Prostate Cancer
Treatment Sterotactic Body Radiotherapy, Conventionally Fractionated Radiation
Clinical Study IdentifierNCT04861415
SponsorDr. Gerard Morton
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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