To hear about similar clinical trials, please enter your email below
Trial Title:
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
NCT ID:
NCT05884632
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Daily Adaptive RadioTherapy
Description:
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
Arm group label:
Treatment arm
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Sacro Cuore Don Calabria di Negrar
Address:
City:
Negrar
Zip:
37024
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Nicosia, Doctor
Phone:
+39(0)456014800
Email:
luca.nicosia@sacrocuore.it
Start date:
April 3, 2023
Completion date:
April 30, 2030
Lead sponsor:
Agency:
IRCCS Sacro Cuore Don Calabria di Negrar
Agency class:
Other
Source:
IRCCS Sacro Cuore Don Calabria di Negrar
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884632
