Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2029-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT delivered with CBCT-guided online adaptive RT

Patients will undergo CT guided online adaptive SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25Gy in 5 fractions ENI to PA nodes (+/- pelvic nodes).

Group Type EXPERIMENTAL

Adaptive radiotherapy using SBRT

Intervention Type 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)

Interventions

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Adaptive radiotherapy using SBRT

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)

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No