NCT05668351

Brief Summary

This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
18mo left

Started May 2023

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
May 2023Jan 2028

First Submitted

Initial submission to the registry

December 6, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

December 6, 2022

Last Update Submit

February 17, 2026

Conditions

Prostate Cancer

Keywords

stereotactic body radiation therapystereotactic ablative body radiotherapySBRTSABRpudendal artery

Outcome Measures

Primary Outcomes (2)

  • 12 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score

    EPIC score at 12 months post intervention will be compared with pre-intervention scores. Score scale is 0 to 100 with lower scores indicating more severe symptoms.

    12 months

  • 12 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score

    EPIC score at 12 months post intervention will be compared with pre-intervention scores. Score is 0 to 100 with lower scores indicating more severe symptoms.

    12 months

Secondary Outcomes (7)

  • 24 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score

    24 months

  • 24 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score

    24 months

  • Incidence of Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 3 or higher adverse events from radiation therapy

    24 months

  • 1 month genitourinary toxicity as assessed by the International Prostate Symptom Score (IPSS)

    1 month

  • 12 and 24 month erectile function as assessed by the Sexual Health Inventory for Men (SHIM) score.

    24 months

  • +2 more secondary outcomes

Study Arms (1)

SUPR-SABR treatment

EXPERIMENTAL

The prescription dose of this study will be 40 Gy in 5 fractions assigned to PTV\_4000 which permits sparing of the rectum, urethra and pudendal artery. There will be a secondary dose level of 36.25 Gy in 5 fractions. A minimum dose of 36.25 Gy will be given to the entire prostate PTV\_3625. 36.25 Gy in five fractions is currently endorsed as a standard of care for localized prostate cancer by the National Comprehensive Cancer Network guidelines in prostate cancer. Escalating the therapeutic radiation dose above 36.25 Gy provides potential for improved biochemical control of prostate cancer and decrease in relapse free survival.

Radiation: SUPR-SABR treatment

Interventions

SUPR-SABR treatmentRADIATION

SUPR-SABR prescription dose to the PTV\_4000 will be 8 Gy per fraction for five fractions. The prescription dose to PTV\_3625 will be a minimum of 7.25 Gy per fraction for five fractions. SABR will be delivered 2-3 times a week, every other day. There will be a minimum of 40 hours between fractions and maximum of 128 hours between fractions.

SUPR-SABR treatment

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsdiagnosis of prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male patients aged 18 years and older
  • In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment
  • Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen
  • Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy)
  • Localized adenocarcinoma of the prostate with the following features:
  • cT1-T2c
  • PSA\<20
  • Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10
  • Grade Group 1-3
  • Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment
  • Prostate volume \<120 cc
  • History and physical including a digital rectal exam 90 days prior to registration
  • ECOG performance status 0-2
  • +3 more criteria

You may not qualify if:

  • Female patients (due to lack of prostate gland)
  • Concurrent use of testosterone supplementation
  • Known homozygous for ATM pathogenic mutation
  • Prior pelvic RT
  • Treatment with another investigational drug for prostate cancer
  • Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT
  • Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years
  • Patients with distant metastases from prostate cancer
  • Patients with lymph node involvement by prostate cancer
  • Prior prostatectomy, cryotherapy, high-intensity focused ultrasound, pelvic irradiation overlapping with fields needed for prostate cancer treatment, prostate brachytherapy, or previous cytotoxic chemotherapy for prostate cancer
  • Unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Harriet Eldredge-Hindy, MD

    MUSC Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Stereotactic Ablative Body Radiotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 29, 2022

Study Start

May 12, 2023

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2028

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)