MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT07644598
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microboost SBRT — RADIATION
    Microboost SBRT at a dose of 45 Gy for 5 fractions
  • Whole gland de-escalation 30 Gy — RADIATION
    Whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.
  • Whole gland de-escalation 35 Gy — RADIATION
    Whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions

Study Details

The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2035

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1- Low Risk
    Patients enrolled to arm 1 will have low risk prostate cancer without Grade Group 2-3 (GG2-3) outside of the microboost target(s). Patients in arm 1 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.
  • Experimental: Arm 2- Intermidiate Risk
    Patients enrolled to arm 2 will have intermidiate risk prostate cancer with grade group 2-3 disease outside of the microboost target(s). Patients in arm 2 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions.

Primary Outcome Measure

Incidence of acute grade 2 or higher genitourinary toxicity [ Time Frame: during treatment through 90 days after radiation treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007
TBD TBD

Find similar trials in Washington D.C., DC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DC

Related Studies