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Clinical Trials in Canada / NCT02623933
Active, not recruiting Not applicable

MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

NCT02623933 · tracked via the Priya Life Science Canada tracker
Sponsor
Sunnybrook Health Sciences Centre
Phase
Not applicable
Started
2015-09-24
Last updated
2022-06-14

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MRI assisted focal boost with HDR monotherapy

MRI assisted focal boost with HDR monotherapy: 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

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed diagnosis of adenocarcinoma of the prostate 2. Low and Intermediate risk disease defined as T1-T2c, Gleason \< 7 and PSA \< 20 ng/ml. 3. Prostate volume \< 60 cc as determined by US, CT or MRI 4. Ability to undergo MR imaging 5. Provide written informed consent 6. Identified MR nodule (PIRADs 4/5) Exclusion Criteria: 1. Ineligible for MR imaging due to contraindications 2. Documented nodal or distant metastases 3. Previous pelvic radiotherapy 4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU 5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted 6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15 7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease 8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Health Sciences Centre Toronto Ontario

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Other trials for the same condition

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs Recruiting
Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process Recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer Recruiting
MRI Guided Focal Laser Ablation of Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02623933 on ClinicalTrials.gov ↗ ← All trials in Canada