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NCT02623933Active, not recruiting

MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)

Source: ClinicalTrials.gov · Last updated 14 Jun 2022

Brief summary (registry, in English)

Radiation therapy plays an important role in the management of prostate cancer. In recent years it has become evident that higher doses of radiation are required to optimize disease control. The limiting factor of escalating dose to the prostate is the surrounding normal tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. As such there is growing interest in further dose escalating to the area of primary disease burden.The aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
60 (actual)
First submitted
3 Dec 2015
Start date
24 Sept 2015
Primary completion date
30 May 2017
Lead sponsor
Sunnybrook Health Sciences Centre
NCT number
NCT02623933

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 24 Sept 2015 to the primary completion date, 30 May 2017
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous pelvic radiotherapy
  • Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
  • Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted

Other illness

  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease

Other

  • Ineligible for MR imaging due to contraindications
  • Documented nodal or distant metastases
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Who the study is looking for

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Low and Intermediate risk disease defined as T1-T2c, Gleason \< 7 and PSA \< 20 ng/ml.
  • Prostate volume \< 60 cc as determined by US, CT or MRI
  • Ability to undergo MR imaging
  • Provide written informed consent
  • Identified MR nodule (PIRADs 4/5)

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sunnybrook Health Sciences Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.