Study Summary
This trial is testing a new, MR-guided 3D ultrasound technique to see if it can more effectively treat prostate cancer while sparing the surrounding nerves and vessels.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Until study completion with 5 years of follow up
1 month after intervention
Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.
Month 60
Acute and long-term GU and GI toxicity
Biochemical failure
Number of patient with preserved erectile function Erectile Function (IIEF) >= 18)
Month 60
Post-procedure PSA dynamic
Year 5
Local recurrence
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Prostate Cancer Patients
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Low dose rate (LDR) brachytherapy · No Placebo Group · N/A
Prostate Cancer Patients
Radiation
Experimental Group · 1 Intervention: Low dose rate (LDR) brachytherapy · Intervention Types: RadiationTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until study completion with 5 years of follow up
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
613 Previous Clinical Trials
402,111 Total Patients Enrolled
15 Trials studying Prostate Cancer
635 Patients Enrolled for Prostate Cancer
Lucas Mendez, MDPrincipal InvestigatorLondon Health Sciences Centre- London Regional Cancer Program
Eligibility Criteria
Age 18 - 75 · Male Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have low- or favourable intermediate-risk prostate cancer.
You have no contraindications to prostate LDR brachytherapy.
You have no or mild erectile function impairment (score ≥18 in IIEF-5).
References
- Sun, Yue, Wu Qiu, Jing Yuan, Cesare Romagnoli, and Aaron Fenster. 2015. “Three-dimensional Nonrigid Landmark-based Magnetic Resonance to Transrectal Ultrasound Registration for Image-guided Prostate Biopsy”. Journal of Medical Imaging. SPIE-Intl Soc Optical Eng. doi:10.1117/1.jmi.2.2.025002.
- Mulhall, John, Absaar Ahmed, Marilyn Parker, and Najeeb Mohideen. 2005. “ORIGINAL RESEARCH—ERECTILE DYSFUNCTION: The Hemodynamics of Erectile Dysfunction Following External Beam Radiation for Prostate Cancer”. The Journal of Sexual Medicine. Elsevier BV. doi:10.1111/j.1743-6109.2005.20362.x.
- Mabjeesh, N, J Chen, A Beri, A Stenger, and H Matzkin. 2004. “Sexual Function After Permanent 125i-brachytherapy for Prostate Cancer”. International Journal of Impotence Research. Springer Science and Business Media LLC. doi:10.1038/sj.ijir.3901271.
- Chasseray, Matthieu, Gurvan Dissaux, Vincent Bourbonne, Nicolas Boussion, Gaelle Goasduff, Julien Malloreau, Jean-Pierre Malhaire, et al.. 2019. “Dose to the Penile Bulb and Individual Patient Anatomy Are Predictive of Erectile Dysfunction in Men Treated with 125i Low Dose Rate Brachytherapy for Localized Prostate Cancer”. Acta Oncologica. Informa UK Limited. doi:10.1080/0284186x.2019.1574981.
- Crook, Juanita Mary, Alfonso Gomez-Iturriaga, Kris Wallace, Clement Ma, Sharon Fung, Shabbir Alibhai, Michael Jewett, and Neil Fleshner. 2011. “Comparison of Health-related Quality of Life 5 Years After SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2010.31.7305.
- Putora, P. M., D. Engeler, S. R. Haile, N. Graf, K. Buchauer, H. P. Schmid, and L. Plasswilm. 2015. “Erectile Function Following Brachytherapy, External Beam Radiotherapy, or Radical Prostatectomy in Prostate Cancer Patients”. Strahlentherapie Und Onkologie. Springer Science and Business Media LLC. doi:10.1007/s00066-015-0928-x.
- Crook, Juanita Mary, Alfonso Gomez-Iturriaga, Kris Wallace, Clement Ma, Sharon Fung, Shabbir Alibhai, Michael Jewett, and Neil Fleshner. 2011. “Comparison of Health-related Quality of Life 5 Years After SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2010.31.7305.
- Chasseray M, Dissaux G, Bourbonne V, Boussion N, Goasduff G, Malloreau J, Malhaire JP, Fournier G, Tissot V, Pradier O, Valeri A, Schick U. Dose to the penile bulb and individual patient anatomy are predictive of erectile dysfunction in men treated with 125I low dose rate brachytherapy for localized prostate cancer. Acta Oncol. 2019 Jul;58(7):1029-1035. doi: 10.1080/0284186X.2019.1574981. Epub 2019 Feb 14.
- Mabjeesh N, Chen J, Beri A, Stenger A, Matzkin H. Sexual function after permanent 125I-brachytherapy for prostate cancer. Int J Impot Res. 2005 Jan-Feb;17(1):96-101. doi: 10.1038/sj.ijir.3901271.
- Mulhall J, Ahmed A, Parker M, Mohideen N. The hemodynamics of erectile dysfunction following external beam radiation for prostate cancer. J Sex Med. 2005 May;2(3):432-7. doi: 10.1111/j.1743-6109.2005.20362.x.
- Lucas Mendez 2021. "Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718987.
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