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Recruiting

NCT Number: NCT04861415

SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterotactic Body Radiotherapy

Radiation

Hypofractionated stereotactic radiation treatment.

Other names: SBRT

Conventionally Fractionated Radiation

Radiation

External beam radiation therapy treatment

Primary outcomes

  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 outcomes

  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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Dr. Gerard Morton

Other

Registry information

Official study title

A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer

Acronym: SHARP

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Apr 27, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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