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Recruiting NCT05884632

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Daily Adaptive RadioTherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation Daily 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

Primary outcome measures

  • Acute gastrointestinal toxicity [Time frame: 90 days from the RT treatment]
Secondary outcome measures (7)
  • Acute genitourinary toxicity [Time frame: 90 days from the RT treatment.]
  • Late toxicity [Time frame: From 90 days after the RT treatment until 24 months]
  • QLQ-C30 [Time frame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months]
  • Biochemical failure [Time frame: 24 months]
  • Time to biochemical failure [Time frame: 24 months]
  • Local in-field relapse [Time frame: 24 months]
  • Metastases-free survival [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Age ≤ 80 years;
  • Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
  • Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
  • No distant metastases (M0) diagnosed with PSMA-PET-CT;
  • Informed consent to trial's participation and personal data treatment.

Exclusion criteria

  • Age <18 years old;
  • Adjuvant radiotherapy;
  • Previous radiation in the same anatomical site.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • IRCCS Sacro Cuore Don Calabria di Negrar — Negrar

Identifiers

NCT: NCT05884632 · 2022-51

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗