RE-irradiation for Isolated FOCal Recurrence of Prostate Cancer With Ultrahypofracted SBRT

NCT07810660 | Not Yet Recruiting

• 2 other identifiers: UID 5402L2-653
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prostate cancer (PCa) is one of the most frequently diagnosed malignancies in men worldwide, with the highest prevalence observed in developed countries. Patients affected by localized disease can be treated with several local modalities, including radical prostatectomy (RP), external beam radiotherapy (EBRT) and brachytherapy (BT). Although the advances in treatment strategies, after primary treatment 5 to 60% of men experience biochemical recurrence (BCR).

Conditions

Prostate Cancer

Keywords

local recurrence; RE-irradiation

Outcome Measures

Primary Outcomes (7)

• Acute GU adverse events

  Acute GU adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

  at the end of treatment and 3 months after the end of treatment

• Acute GI adverse events

  Acute GI adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

  at the end of treatment and 3 months after the end of treatment

• questionnaire IIEF-5

  The patient fills out the questionnaire IIEF-5

  At the baseline and from the end of radiotherapy through study completion, every three months.

• questionnaire IPSS

  The patient fills out the questionnaire IPSS

  At the baseline and from the end of radiotherapy through study completion, every three months.

• questionnaire QLQ-C30

  The patient fills out the questionnaire QLQ-C30

  At the baseline and from the end of radiotherapy through study completion, every three months.

• Late GU adverse events (CTCAE)

  Late GU adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

  From 6 months after the end of radiotherapy until the end of the study, every six months.

• Late GI adverse events (CTCAE)

  Late GI adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)

  From 6 months after the end of radiotherapy until the end of the study, every six months.

Secondary Outcomes (1)

• Biochemical progression-free survival (bPFS)

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All enrolled patients will receive standard-of-care CyberKnife-based SBRT to the pelvic target. Androgen deprivation therapy (ADT), including its indication, timing, and duration, will be prescribed at the discretion of the treating radiation oncologist based on clinical judgment and individual patient characteristics.

You may qualify if:

• Age \> 18 and \< 80 years
• Histologically confirmed adenocarcinoma of the prostate initial diagnosis
• History of a previous adjuvant/salvage RT following prostatectomy or curative RT
• Diagnosis of local recurrence at the restaging imaging in hormone sensitive patients (maximum 1 prostate bed recurrence and 3 intraprostatic recurrences)
• DICOM plan of the previous RT course
• No evidence of greater than grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) or gastrointestinal (GI) late adverse events from the previous RT course
• Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
• Good urinary flow (peak flow \>10 mL/s) or IPSS \< 15
• Written informed consent for treatment and research purpose

You may not qualify if:

• Evidence of distant metastasis at the restaging imaging
• Patients with current concomitant anticoagulant therapy (antiplatelet therapy is allowed even if it will be temporary suspended before fiducials implant)
• Platelets count \< 75'000/uL
• Urethral stricture
• Having received previous different salvage treatments for PCa local relapse
• Development of BCR while on ADT
• Concomitant inflammatory bowel disease or other serious systemic comorbidities
• Presence of hip prosthesis
• Impossibility of performing an MRI

Sponsors & Collaborators

• European Institute of Oncology: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• BARBARA A JERECZEK-FOSSA, MD, PhD

  European Institute of Oncology, Milano. Mi, Italy 20141

  PRINCIPAL INVESTIGATOR

• BARBARA JERECZEK-FOSSA, MD, PhD

  European Institute of Oncology, Milano. Mi, Italy 20141

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BARBARA A JERECZEK-FOSSA, MD, PhD

CONTACT

+39 0257489037; barbara.jereczek@ieo.it

GIULIA MARVASO, MD

CONTACT

+39 0257489037; giulia.marvaso@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: September 9, 2026

Record last verified: 2026-07