Status:

RECRUITING

2 Ablative RadioTherapy Treatments for Prostate Cancer

Lead Sponsor:

Sunnybrook Health Sciences Centre

Conditions:

Prostate Cancer

Eligibility:

MALE

Phase:

PHASE2

PHASE3

Brief Summary

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protract...

Detailed Description

Pre-Treatment: Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Cent...

Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate

  • Favorable risk disease defined as either:

    • Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
    • Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
  • Prostate volume < 60 cc as determined by US, CT or MRI

  • Ability to undergo MR imaging

  • Provide written informed consent

Exclusion Criteria:

  • Documented nodal or distant metastases
  • Previous pelvic radiotherapy
  • Previous transurethral 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 anaesthesia

Key Trial Info

Start Date :

July 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 29 2028

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04654338

Start Date

July 29 2020

End Date

July 29 2028

Last Update

June 27 2023

Active Locations (1)

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1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5