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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05884632
Other study ID # 2022-51
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date April 30, 2030

Study information

Verified date May 2023
Source IRCCS Sacro Cuore Don Calabria di Negrar
Contact Elvia Malo
Phone +390456014854
Email ricerca.clinica@sacrocuore.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date April 30, 2030
Est. primary completion date April 30, 2030
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy IRCCS Sacro Cuore Don Calabria di Negrar Negrar Verona

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute gastrointestinal toxicity Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade =G2. 90 days from the RT treatment
Secondary Acute genitourinary toxicity Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment. 90 days from the RT treatment.
Secondary Late toxicity Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment. From 90 days after the RT treatment until 24 months
Secondary QLQ-C30 Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
Secondary Biochemical failure PSA raise after RT from nadir 24 months
Secondary Time to biochemical failure Time between salvage RT and biochemical failure 24 months
Secondary Local in-field relapse Local in-field relapse evaluated with PET-CT or RM 24 months
Secondary Metastases-free survival Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise 24 months
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