MRI Guided SBRT for Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03778112|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: SBRT to whole prostate Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer|
|Actual Study Start Date :||May 23, 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Negative mpMRI Prostate Scan
SBRT to the whole prostate
Radiation: SBRT to whole prostate
Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate
Experimental: Positive mpMRI Prostate Scan
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
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
- Rate of Late Radiation Induced Genitourinary and Gastrointestinal Toxicity [ Time Frame: 18 months ]
- Rate of Acute Radiation Induced Genitourinary Toxicity [ Time Frame: 3 months ]
- Biochemical Recurrence [ Time Frame: 18 months ]
- Disease Free-Survival [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778112
|Contact: Robert Stines, RNfirstname.lastname@example.org|
|Contact: Riley J Sticca, BS, CCRP||312-563-5769|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Dian Wang, MD, PhD 312-942-5751 email@example.com|
|Contact: Mudit Chowdhary, MD 312-942-1210 firstname.lastname@example.org|
|Principal Investigator: Dian Wang, MD, PhD|
|Sub-Investigator: Mudit Chowdhary, MD|
|Principal Investigator:||Dian Wang, MD, PhD||Rush University Medical Center|