Clinical Trial: NCT03778112 - My Cancer Genome

NCT03778112

Description:

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.

Related Conditions:

Prostate Adenocarcinoma

Recruiting Status:

Active, not recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03778112

Trial Eligibility

Document

Title

Brief Title: MRI Guided SBRT for Localized Prostate Cancer
Official Title: Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer

Clinical Trial IDs

ORG STUDY ID: mpMRI SBRT Prostate
SECONDARY ID: 15060207
NCT ID: NCT03778112

Conditions

Prostate Cancer

Purpose

Detailed Description

      Radiotherapy (RT) is considered standard of care treatment for prostate cancer. Conventional
      RT regimens consist of 8-9 weeks of daily RT. Recent data support the use of hypofractionated
      RT (5-6 weeks) due to similar disease control in a contracted treatment time. This study
      combines the benefits of RT dose escalation while shortening the overall RT treatment course.

      In this protocol, patients will undergo a pretreatment mpMRI prostate scan and be stratified
      to two separate SBRT regimens depending on whether prostate lesions are present. For patients
      without any positive mpMRI lesions, an SBRT monotherapy (36.25 Gy in 5 fractions) approach
      will be utilized. Patients with an equivocal or positive mpMRI lesion(s), will receive
      IG-IMRT (45 Gy in 25 fractions) to prostate and seminal vesicle +/- lymph nodes followed by a
      SBRT whole prostate boost (18 Gy in 3 fractions) with a simultaneously integrated boost (SIB)
      (21 Gy in 3 fractions) to intraprostatic lesion(s) only.

      Patients will be regularly assessed every 3 months for the first 2 years and then every 6
      months, indefinitely. Side effects will be monitored using the standardized international
      prostate symptom score (I-PSS) and Sexual Health Inventory of Men (SHIM) questionnaires at
      baseline and subsequent follow-up appointments.

      Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk
      prostate cancer nodules and deliver a higher effective RT dose, to achieve maximal tumor
      control without increasing toxicity, all in a shortened treatment duration.

Trial Arms

Name	Type	Description	Interventions
Negative mpMRI Prostate Scan	Experimental	SBRT to the 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

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Male
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
Time Frame:	18 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Rate of Acute Radiation Induced Genitourinary Toxicity
Time Frame:	3 months
Safety Issue:
Description:

Measure:	Biochemical Recurrence
Time Frame:	18 months
Safety Issue:
Description:

Measure:	Disease Free-Survival
Time Frame:	18 months
Safety Issue:
Description:

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Rush University Medical Center

Trial Keywords

Prostate Cancer
Radiotherapy
SBRT
Stereotactic Body Radiotherapy
MRI

Last Updated

January 26, 2021

Clinical Trials /

MRI Guided SBRT for Localized Prostate Cancer