Phase I Study MR-guided SBRT to PCa

Overview

1) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction

Full Title of Study: “Phase I Study Of MR-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost (SIB) To the Dominant Intraprostatic Lesion(s) (DILs) in Men With Localized Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Radiation: MR guided Linear Accelerator
    • The aim is to perform treatment planning to compute the highest feasible simultaneous boosting dose to the intraprostatic lesion while respecting normal tissue dose constraints. Patients will be treated with MR-guided localization and adaptive planning techniques.

Arms, Groups and Cohorts

  • Experimental: MR-guided SBRT With SIB to the DILs to Prostate Cancer
    • Dose escalation to the DIL(s) will be performed in the traditional Phase I 3+3 design. Patients will be treated in four cohorts (three patients per dose level) starting with a dose of 9 Gy to the DIL(s). If no dose limiting toxicity (DLT), defined below, is observed after 90 days, then an additional three patients will be entered at the next dose level. Dose to the DIL(s) will be escalated at 1 Gy increments until DLT is observed or if maximum dose level (60 Gy in 5 fractions of 12 Gy) is reached with no observed DLT. If one of the three patients experience a DLT at a particular dose level an additional three patients will be enrolled at that level. If two or more patients experience a DLT a lower dose level will be explored to define the maximum tolerated dose (MTD). The three patients within any cohort can be enrolled simultaneously or sequentially without any waiting period among them.

Clinical Trial Outcome Measures

Primary Measures

  • Determine the maximum tolerated dose to DILs until dose limiting toxicity (>=3 grade 3 GI/GU toxicity) is observed or if maximum dose level is reached
    • Time Frame: 2 years
    • The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT

Secondary Measures

  • Quality of Life measures using the Epic questionnaire
    • Time Frame: 2 years
    • Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically confirmed prostate adenocarcinoma. – Patients with low or favorable intermediate risk prostate cancer and patients with unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy – Pretreatment evaluations must be completed as specified in Section 4.0 – Patients must sign a study-specific informed consent form prior to study participation. – No contraindication to MRI. For example, patients with metal fragments or implanted devices such as pacemakers and aneurysm clips may not be eligible for the study – At least one intraprostatic lesion can be identified on the mpMR images. – Patients agree to have hydrogel placed. Exclusion Criteria:

  • Patients who have a contraindication to contrast-enhanced MRI are not eligible. Patients with an implanted device such as a pacemaker or metal fragments are not eligible.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henry Ford Health System
  • Collaborator
    • American Cancer Society, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephen Brown, co-Lead, Translational Oncology Research, Henry Ford Cancer Institute – Henry Ford Health System

References

Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.

Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.

Pucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ. Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):62-9. doi: 10.1016/j.ijrobp.2007.03.065.

Turkbey B, Mani H, Shah V, Rastinehad AR, Bernardo M, Pohida T, Pang Y, Daar D, Benjamin C, McKinney YL, Trivedi H, Chua C, Bratslavsky G, Shih JH, Linehan WM, Merino MJ, Choyke PL, Pinto PA. Multiparametric 3T prostate magnetic resonance imaging to detect cancer: histopathological correlation using prostatectomy specimens processed in customized magnetic resonance imaging based molds. J Urol. 2011 Nov;186(5):1818-24. doi: 10.1016/j.juro.2011.07.013. Epub 2011 Sep 25.

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