NCT03778112

Brief Summary

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
34mo left

Started May 2016

Longer than P75 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 Progress78%
May 2016Mar 2029

Study Start

First participant enrolled

May 23, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 14, 2023

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Expected
Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

December 14, 2018

Results QC Date

November 2, 2022

Last Update Submit

February 23, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerRadiotherapySBRTStereotactic Body RadiotherapyMRI

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity

    Number of Participants with late grade 3-5 genitourinary and gastrointestinal toxicity following mpMRI guided radiation treatment. Late toxicity will be defined as toxicity occurring more than nine months from the start of radiotherapy.

    18 months

Secondary Outcomes (3)

  • Number of Participants With Acute Radiation Induced Genitourinary Adverse Event

    3 months

  • Biochemical Recurrence

    18 months

  • Disease Free-Survival

    18 months

Study Arms (2)

Negative mpMRI Prostate Scan

EXPERIMENTAL

SBRT to the whole prostate

Radiation: SBRT to whole prostate

Positive mpMRI Prostate Scan

EXPERIMENTAL

IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions

Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions

Interventions

SBRT to whole prostateRADIATION

Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate

Negative mpMRI Prostate Scan
IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesionsRADIATION

Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions

Positive mpMRI Prostate Scan

Eligibility Criteria

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

You may qualify if:

  • Biopsy proven prostate adenocarcinoma within 1 year of randomization
  • NCCN Low to High Risk localized prostate cancer
  • Zubrod Performance Status 0-1 within 60 days prior to registration

You may not qualify if:

  • Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
  • Regional Lymph Node (N1) involvement
  • Distant Metastases (M1) involvement
  • History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
  • Prior chemotherapy
  • Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS)
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Inability to undergo MRI
  • Inability to receive fiducial markers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dian Wang, MD
Organization
Rush University Medical Center
Dian_Wang@rush.edu
(708) 660-3476

Study Officials

  • Dian Wang, MD, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

May 23, 2016

Primary Completion

March 1, 2019

Study Completion (Estimated)

March 1, 2029

Last Updated

March 9, 2026

Results First Posted

February 14, 2023

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)