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

Dr. Gerard Morton

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Conventionally Fractionated Radiation; Radiation: Sterotactic Body Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04861415

2734

Details and patient eligibility

About

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

Full 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

Enrollment: 55 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Conventional Fractionated Radiation

Active Comparator group

Description:

* 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

Treatment:

Radiation: Conventionally Fractionated Radiation

Stereotactic Body Radiotherapy

Experimental group

Description:

* 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

Treatment:

Radiation: Sterotactic Body Radiotherapy