Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed prostate adenocarcinoma.

Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.

≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.

ECOG performance status 0-2.

Disqualifiers

Prior radiotherapy to the nodal echelon (PA +/- common iliac).

Active secondary malignancy, except for adequately treated non-melanoma skin cancer.

Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.

Contraindication to radiation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adaptive radiotherapy using SBRT

    Radiation

    Adaptive External beam radiotherapy using SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25 Gy in 5 fractions ENI to PA nodes (+ common iliac nodes)

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: SBRT delivered with CBCT-guided online adaptive RTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quantify adverse events using CTCAE v5.0

Acute toxicities (≤3 months) and long-term toxicities (related to urinary, bowel or sexual function) will be collected and evaluated by the CTCAE v5.0.

Time frame
2 years

Secondary outcomes

1

QoL using EPIC questionnaire

Quality of life (QOL) will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.

Time frame
2 years
2

Pain levels using EPIC questionnaire

Pain levels will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.

Time frame
2 years
3

Urinary function using EPIC questionnaire

Urinary function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.

Time frame
2 years
4

Bowel function using EPIC questionnaire

Bowel function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.

Time frame
2 years

Other outcomes

Sponsors and contacts

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