Phase I Study MR-guided SBRT to PCa

Low or Intermediate Risk Prostate Cancer Clinical Trial

— MRgRTPCa  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03935308
• Other study ID #: MRgSBRT
• Status: Withdrawn
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low or Intermediate Risk Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT	2 years
Secondary	Quality of Life measures using the Epic questionnaire	Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.	2 years