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5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

Recruiting
18 years and older
Male
Phase N/A

Overview

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Eligibility

Inclusion Criteria

  • Histologically confirmed prostate adenocarcinoma (centrally reviewed)
  • High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
  • High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

  • Prior pelvic radiotherapy
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
  • Diagnosis of bleeding diathesis
  • Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
  • Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
  • Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
  • Hip prosthesis

Study details
    Malignant neoplasm of prostate
    Prostatic disorder

NCT04245670

Sunnybrook Health Sciences Centre

16 February 2024

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