5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

  • STATUS
    Recruiting
  • participants needed
    75
  • sponsor
    Sunnybrook Health Sciences Centre
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Updated on 19 February 2024
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adenocarcinoma
stereotactic body radiation therapy
adenocarcinoma of prostate

Summary

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder
Age 18years - 100years
Treatment Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5
Clinical Study IdentifierNCT04245670
SponsorSunnybrook Health Sciences Centre
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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