Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
NCT05884632

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

Led by IRCCS Sacro Cuore Don Calabria di Negrar · Updated on 2023-06-01

184

Participants Needed

1

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 80 years or younger
  • Diagnosed with prostate cancer, stage pT2-3 pN0, any surgical margin status (R0 or R1)
  • Eligible for local salvage treatment, defined as early salvage radiotherapy after prostate surgery with PSA below 0.2 ng/ml or salvage radiotherapy with PSA 0.2 ng/ml or higher
  • No distant metastases confirmed by PSMA-PET-CT
  • Provided informed consent for trial participation and personal data use
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Receiving adjuvant radiotherapy
  • Prior radiation treatment in the same anatomical area

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy, 37024

Actively Recruiting

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Research Team

E

Elvia Malo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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