Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

Recruiting

• Conditions: Prostate Cancer (Post Prostatectomy)

• Registration Number: NCT06941363
• Lead Sponsor: University of Milano Bicocca

Brief Summary

Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility

Detailed Description

Patients enrolled in this observational prospective trial undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as per clinical practice. Eligible patients are those with (1) persistently detectable PSA post-operatively or (2) developing biochemical recurrence after prostatectomy with initially undetectable PSA, without evidence of macroscopic local relapse and/or regional and distant metastases at restaging, proposed for receiving up to 15 Gy in a single session to the prostate bed.

As per current practice, in case of PSMA positivity at the level of prostate bed, the treatment will be intended to cover this area up to 110% of the prescribed dose yet respecting the OARs constraints.

Patients will be followed at approximately one month, then approximately every 3 months for the first 12 months and every 6 months thereafter. At follow-up visit patients will be evaluated for urinary, rectal, and sexual toxicity. Baseline measures of these domains will be obtained prior to treatment. Serum PSA values will be drawn on the same schedule as clinical follow-up.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Study Start: 2025-05
• Primary Completion: 2033-05
• Study Completion: 2033-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Subjects of male sex ≥ 18 years of age.

• Subjects have freely signed the pertinent informed consent before the beginning of the study

  • Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
  • Detectable post-prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable)
  • No evidence of N1 and/or M1 disease assessed by PSMA PET-CT within 90 days prior to registration
  • Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT
  • Androgen deprivation therapy (ADT) allowed as per physician's discretion
  • ECOG performance status of 0-1
  • Ability to complete the questionnaires

Exclusion Criteria

• N1 and or M1 patients
• Macroscopic local relapse at pelvic MRI.
• Prior radiation of any kind to the prostate gland or pelvis
• Prior brachytherapy
• History of inflammatory colitis or other active severe comorbidities
• Patients who are on immunosuppressant medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v. 5.0	60 months	To prospectively evaluate the cumulative incidence of acute (\< 90 days from the end of treatment) and late (\> 90 days) treatment related toxicities and adverse events

Secondary Outcome Measures

Name	Time	Method
Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL)	60 months	To assess biochemical outcome after postoperative SBRT using serum PSA levels
QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-CP) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL	60 months	To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-CP Questionnaire
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst)	60 months	To assess urinary continence after postoperative SBRT using ICIQ-SF
Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best)	60 months	To assess erectile function after postoperative SBRT using IIEF 5

Trial Locations

Locations (1)

Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca); 🇮🇹 Monza, Italy