RecruitingNot ApplicableNCT05884632

Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients


Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

184 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence. Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether daily adaptive radiation therapy — where the radiation plan is adjusted each day based on how the prostate area looks — can improve outcomes for men who need radiation after prostate cancer surgery when their PSA has risen or remained detectable. **You may be eligible if...** - You are 80 years old or younger - You have had your prostate surgically removed (radical prostatectomy) for prostate cancer - Your cancer was stage pT2–3 and did not spread to the lymph nodes - You need salvage radiation because your PSA has risen or did not fall low enough after surgery - You have no evidence of cancer spread (confirmed by a PSMA PET-CT scan) - You have not had any prior radiation to the pelvic area **You may NOT be eligible if...** - You are under 18 years old - You received adjuvant radiotherapy right after surgery - You have previously had radiation in the same area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDaily Adaptive RadioTherapy

Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy


Locations(1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

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NCT05884632


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