SBRT Boost for Unfavorable Prostate Cancer'

ConditionProstate Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorMemorialCare Health System

About this trial

The purpose of this study is to find out whether giving a short course of focused radiation called an SBRT "boost" is a safe and effective way to treat prostate cancer. This boost delivers a high dose of radiation to the prostate in a non-invasive way, similar to what is done with high dose rate (HDR) brachytherapy but without using needles. The study looks at how well this treatment controls the cancer, what side effects it may cause, and how it affects patients' quality of life over time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven prostate adenocarcinoma

Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient.

Clinical Stage I-IV, MX-M0 (AJCC VERSION 9)

M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Stereotactic body radiotherapy (SBRT) Boost
Radiation
The intervention in this study is the SBRT boost, which is a short course of five high-dose stereotactic body radiotherapy treatments (5.5 Gy × 5 fractions, total 27.5 Gy) delivered with image-guided precision to the prostate. This SBRT boost is given in addition to standard external-beam radiation therapy (EBRT), which delivers 50.4 Gy to the pelvis, prostate, and proximal seminal vesicles.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Stereotactic Body Radiation Therapy BoostExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of Grade 3-5 Gastrointestinal (GI) and Genitourinary (GU) Toxicities

This outcome measures how many participants experience severe (grade 3-5) side effects involving the gastrointestinal or genitourinary systems after receiving the SBRT boost. Toxicities are evaluated using the NCI Common Terminology Criteria for Adverse Events (CTCAE).

Time frame

5 years

Secondary outcomes

Local Failure Rate

The study looks at whether the cancer comes back in the prostate or spreads elsewhere, how long patients stay cancer-free, and how long they live with or without prostate cancer. It also measures overall survival from any cause and tracks changes in urinary and sexual function using brief questionnaires over time. These outcomes are monitored throughout regular follow-up visits for up to 5 years, with some patients followed as long as 10 years if the investigators choose to continue long-term monitoring.

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MemorialCare Health System

Lead sponsor

Source ClinicalTrials.gov

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