Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

N/ANot Yet RecruitingNCT06831032

University Health Network, Toronto26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Adenocarcinoma Iliac Nodal Disease Para-aortic Lymph Node Metastasis Para-aortic Nodal Disease Oligorecurrence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed prostate adenocarcinoma. 2. Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT. 3. ≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging. 4. ECOG performance status 0-2. Exclusion Criteria: 1. Prior radiotherapy to the nodal echelon (PA +/- common iliac). 2. Active secondary malignancy, except for adequately treated non-melanoma skin cancer. 3. Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study. 4. Contraindication to radiation.

Outcomes

Primary Outcomes

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

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

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

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

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

Assessment of adaptive RT approach using dose accumulation

Dosimetric assessment of the CBCT-guided online adaptive RT approach using dose accumulation.

Time frame: 2 years

Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts