Brief Summary

This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). For patients with prostate cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy, salvage radiation therapy is the standard of care treatment. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage radiation following radical prostatectomy typically have treatment directed to the prostate fossa, which is the anatomical region around the operative bed that is at highest risk for containing left over tumor. Many patients receiving salvage radiation therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy is an emerging treatment technique that uses daily imaging to adjust treatment volumes, ensure accurate dose delivery, and allow the use of smaller planning target volume margins. Adaptive radiation is ideally suited for the further implementation of SABR treatment regimens directed to the prostate fossa with or without inclusion of the pelvic lymph nodes. While daily adaptive radiation therapy has been reported in other disease settings, there is currently no data about its use for post-prostatectomy radiation. Using daily adaptive radiation techniques may help researchers learn how to minimize exposure to normal tissue and shorten the number of required treatments to better target the radiation dose in prostate cancer patients post-prostatectomy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

37mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.8 years study duration

Study Progress48%

Jul 2023May 2029

First Submitted

Initial submission to the registry

April 1, 2023

Completed

25 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed

3 months until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

April 1, 2023

Last Update Submit

May 16, 2025

Conditions

Malignant Prostate Neoplasm

Outcome Measures

Primary Outcomes (1)

Observe Grade 3 genitourinary and gastrointestinal toxicity rate to demonstrate safety of daily adaptive online replanning
Acute and late Common Terminology Criteria for Adverse Events version 5.0 grade 2 or greater genitourinary and gastrointestinal toxicity will be recorded for all patients. Will report the overall grade 3+ toxicity rate along with a 95% confidence interval for this endpoint. Metrics related to treatment times for each fraction, physician choice of baseline vs adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well.
Up to 5 years

Secondary Outcomes (6)

Evaluate successful completion of daily adaptive radiation planning
Up to 5 years
Local failure
From enrollment up to 5 years
Biochemical failure
From baseline up to 5 years
Distant metastasis
From baseline up to 5 years
Assess patient reported changes in urinary, bowel, and sexual outcomes following protocol treatment with the Expanded Prostate Cancer Index Composite-26 (EPIC-26) instrument.
Up to 2 years
+1 more secondary outcomes

Study Arms (2)

Group I (daily adaptive online replanning, SBRT)

EXPERIMENTAL

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo MRI and may undergo PET/CT during screening.

Procedure: Computed TomographyRadiation: Image-Guided Adaptive Radiation TherapyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire AdministrationRadiation: Stereotactic Body Radiation Therapy

Group II (daily adaptive online replanning, SBRT)

EXPERIMENTAL

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI and may undergo PET/CT during screening.

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography