Study Summary
This trial is testing a new way to give radiation therapy to patients with high-risk prostate cancer. The new method features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT).
- Prostate Cancer
Treatment Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 60 months after the end of radiation therapy
Trial Safety
Trial Design
2 Treatment Groups
HR-A (High-risk A)
1 of 2
HR-B (High-risk B)
1 of 2
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: HR-A · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 100 · Male Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Pokorny, Morgan R., Maarten de Rooij, Earl Duncan, Fritz H. Schröder, Robert Parkinson, Jelle O. Barentsz, and Leslie C. Thompson. 2014. “Prospective Study of Diagnostic Accuracy Comparing Prostate Cancer Detection by Transrectal Ultrasound–guided Biopsy Versus Magnetic Resonance (MR) Imaging with Subsequent Mr-guided Biopsy in Men Without Previous Prostate Biopsies”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2014.03.002.
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- Vargas, Carlos, Amber Fryer, Chaitali Mahajan, Daniel Indelicato, David Horne, Angela Chellini, Craig McKenzie, et al.. 2008. “Dose–volume Comparison of Proton Therapy and Intensity-modulated Radiotherapy for Prostate Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2007.07.2335.
- Padhani, Anwar R, Vincent S Khoo, John Suckling, Janet E Husband, Martin O Leach, and David P Dearnaley. 1999. “Evaluating the Effect of Rectal Distension and Rectal Movement on Prostate Gland Position Using Cine MRI”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/s0360-3016(99)00040-1.
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- Pugh, Thomas J., Mark F. Munsell, Seungtaek Choi, Quyhn Nhu Nguyen, Benson Mathai, X. Ron Zhu, Narayan Sahoo, et al.. 2013. “Quality of Life and Toxicity from Passively Scattered and Spot-scanning Proton Beam Therapy for Localized Prostate Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2013.08.032.
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- Fonteyne, Valérie, Geert Villeirs, Bruno Speleers, Wilfried De Neve, Carlos De Wagter, Nicolas Lumen, and Gert De Meerleer. 2008. “Intensity-modulated Radiotherapy as Primary Therapy for Prostate Cancer: Report on Acute Toxicity After Dose Escalation with Simultaneous Integrated Boost to Intraprostatic Lesion”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2008.01.040.
- Tucker, Susan L., Howard D. Thames, Jeff M. Michalski, Walter R. Bosch, Radhe Mohan, Kathryn Winter, James D. Cox, James A. Purdy, and Lei Dong. 2011. “Estimation of Α/β for Late Rectal Toxicity Based on RTOG 94-06”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2010.11.080.
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- Litzenberg, Dale W., James M. Balter, Scott W. Hadley, Howard M. Sandler, Twyla R. Willoughby, Patrick A. Kupelian, and Lisa Levine. 2006. “Influence of Intrafraction Motion on Margins for Prostate Radiotherapy”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2005.12.033.
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Frequently Asked Questions
Does this research project include elderly participants?
"This medical trial is inviting applicants aged 18 and up, but no older than 100 years old." - Anonymous Online Contributor
Does my condition fulfill the requirements for participation in this experiment?
"Individuals suffering from adenocarcinoma and between the ages of 18 to 100 are eligible for this medical trial. A maximum of one hundred patients may be admitted into the study." - Anonymous Online Contributor
Are there any openings for enrolment in this clinical experiment?
"Affirmative. Evidenced by the clinicaltrials.gov portal, this medical trial is currently recruiting participants, with 100 needed from 1 site. It was initially published on September 24th 2018 and recently edited on September 2nd 2022." - Anonymous Online Contributor
What is the scope of participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the medical trial posted on September 24th 2018 is currently looking for volunteers. One hundred participants are needed from a single research centre." - Anonymous Online Contributor