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NCT Number: NCT02623933

MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

This study is a pilot study of 60 patients look at the toxicities, biochemical and patient reported quality of life outcomes of an MR-integrated focal boost using HDR prostate brachytherapy. Eligible patients for this study will be determined by pre-brachytherapy MRI (DCE, T2 weighted and diffusion weighted) imaging, to identify a dominant intraprostatic lesion. The HDR dose prescription is 19 Gy to the whole gland ad 22.5 Gy to MRI visible lesion delivered in one fraction, assuming that dose constraints to critical organs can be met.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Ineligible for MR imaging due to contraindications
  • Documented nodal or distant metastases
  • 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
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
  • Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Treatment and study plan

MRI assisted focal boost with HDR monotherapy

Radiation

Prior to brachytherapy treatment, a multiparametric MRI will be obtained for identification of the dominant intraprostatic lesion (DIL) and fused with the preplanning transrectal ultrasound. A total of 19 Gy will be prescribed to the prostate, organ at risk limits will be observed and up to 22.5 Gy can be delivered to the DIL

Primary outcomes

  1. Acute GU and GI toxicities

    Time frame: 3mo

    Measured according to NCI CTCAE v4.0

Secondary outcomes

  1. Late GU and GI toxicities

    Time frame: 5 years

    Measured according to NCI CTCAE v4.0

  2. Quality of life changes

    Time frame: 5 years

    Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)

  3. Changes in urinary symptoms

    Time frame: 5 years

    Patient reported outcome utilizing International Prostate Symptom Score (IPSS)

  4. Changes in serum prostate-specific antigen (PSA)

    Time frame: 5 years

  5. PSA failure and disease-free survival rates

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: MARS

Important dates

Study start
2015
Primary completion
2017
Study completion
2027
First posted
Dec 8, 2015
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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