SBRT vs. Conventional Fractionation With HDR Boost for Prostate Cancer

NCT ID: NCT04861415

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2027-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Conventionally Fractionated Radiation

Intervention Type RADIATION

External beam radiation therapy treatment

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

Group Type EXPERIMENTAL

Sterotactic Body Radiotherapy

Intervention Type RADIATION

Hypofractionated stereotactic radiation treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sterotactic Body Radiotherapy

Hypofractionated stereotactic radiation treatment.

Intervention Type RADIATION

Conventionally Fractionated Radiation

External beam radiation therapy treatment

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SBRT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Gerard Morton

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Gerard Morton

Radiation Oncologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerard Morton

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gerard Morton, MD

Role: CONTACT

416-480-6100 ext. 6165

Merrylee McGuffin

Role: CONTACT

416-480-6100 ext. 85454

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gerard Morton, MD, FRCPC

Role: primary

416-480-6100 ext. 6165

Merrylee McGuffin, MSc, MRT(T)

Role: backup

416-480-6100 ext. 85454

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2734

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LDR vs. HDR Brachytherapy for Prostate Cancer
NCT03426748 ACTIVE_NOT_RECRUITING NA
MRI Guided SBRT for Localized Prostate Cancer
NCT03778112 ACTIVE_NOT_RECRUITING NA