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NCT05946824: DASBRT-RPC

This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.

Recruiting now Phase 2 Last updated 8 October 2024
What this trial tests

Phase 2 trial testing Daily-adaptive Stereotactic Body Radiation Therapy in Recurrent Prostate Cancer After Surgery in 80 participants. Currently enrolling.

Timeline
14 December 2023
Primary endpoint
24 November 2025
24 November 2028

Quick facts

Lead sponsorUniversity of Rochester
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date14 December 2023
Primary completion24 November 2025
Estimated completion24 November 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Rochester

Who can join

18 and older, male only, with Recurrent Prostate Cancer After Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Tribulations and future opportunities for artificial intelligence in precision medicine.
    Carini C, Seyhan AA. · · 2024 · cited 67× · PMID 38702711 · DOI 10.1186/s12967-024-05067-0

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Other University of Rochester trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing