24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer

NCT05936736 | Recruiting

• 1 other identifier: PRO-FAST
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.

Conditions

Localized Prostate Carcinoma

Keywords

Prostate Cancer; Single fraction SBRT; Urethral sparing HDR like; PSMA PET/CT; Organ movement; Radiomics

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  Incidence of acute toxicity of grade 3 or 4 as maximum toxicity value during the radiation treatment or in any case within a month of the end of SBRT, using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale (toxicity from 0- patients without toxicity to 5-death from toxicity)

  one month

Secondary Outcomes (12)

• Biochemical control

  5 years (with interim analyzes at 1 and 3 years)

• Biochemical relapse

  5 years (with interim analyzes at 1 and 3 years)

• Local Control

  5 years (with interim analyzes at 1 and 3 years)

• Distant Disease Control

  5 years (with interim analyzes at 1 and 3 years)

• Survival

  5 years (with interim analyzes at 1 and 3 years)

Other Outcomes (2)

• Organ movement

  3 years

• Radiomics

  5 years ( with interim analyzes at 3 years)

Study Arms (1)

24 Gy in one fraction, urethral sparing HDR like

EXPERIMENTAL

Patients with localized prostate cancer - negative PSMA PET CT +/- standard staging exams (bone scan, CT, MRI)-enrolled in this study, will be treated to prostate/prostate seminal vesicles (according to the risk group) to a total dose of 24 Gy delivered in 1 fraction, with a urethral sparing HDR like technique. For unfavorable intermediate and high-risk pts, Androgen Deprivation Therapy (ADT) will be prescribed for 6 and 24 months, respectively. The procedure will be performed in just one day, from fiducials implantation to radiation treatment delivery.

Radiation: prostate SBRT

Interventions

prostate SBRT RADIATION

Patients with prostate cancer will be treated with high-dose SBRT to prostate and seminal vesicles, delivered in one fraction, sparing the urethra and generating a dose distribution similar to HDR brachytherapy

Also known as: ultrahypofractionation, extreme hypofractionation

24 Gy in one fraction, urethral sparing HDR like

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male with prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5
• Patients over 18 years of age
• Signed informed consent
• Negative lymph nodes confirmed by imaging (PSMA PET/CT and/or pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer Network (NCCN) guidelines) in the previous 3 months
• Clinical M0 (PSMA PET/CT and/or bone scan and/or pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3 months
• Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml/s), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the reduction of prostate volume, uroflowmetry is reset to at least ≥ 12 ml/s.
• PS (ECOG) ≤2
• No previous pelvic radiotherapy
• Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)

You may not qualify if:

• Serious systemic diseases
• Psychic or other disorders that may prevent the patient from signing the informed consent
• Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)
• Lymph node disease (N1)
• Evidence of distant metastases (M1)
• IPSS questionnaire data \> 20 points
• Uroflowmetry with maximum basal flow ≤ 11 ml/sec and/or PVR \>100 ml
• Concomitant urinary/gastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)
• Overactive bladder
• Impossibility of implantation of fiducials
• Inability or refusal to place bladder catheter for simulation CT and MR
• Inability to perform simulation MRI
• Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease
• Non-compliance with dose limits established in the treatment plan

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, MI, 20132, Italy

RECRUITING

Related Publications (26)

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  PMID: 40866948 DERIVED

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

• Nadia Di Muzio, Prof

  IRCCS San Raffaele Scientific Institute

  STUDY DIRECTOR

• Andrei Fodor, MD

  IRCCS San Raffaele Scientific institute

  STUDY CHAIR

Central Study Contacts

Andrei Fodor, MD

CONTACT

+390226437634; fodor.andrei@hsr.it

Nadia Di Muzio, Prof

CONTACT

+390226437643; dimuzio.nadia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: According to the optimal design of Simon, 13 pts will be enrolled for the first phase of the study. Hypothesis: the proportion of pts free from acute cumulative G ≥3 toxicity (CTCAE v5.0 scale) 1 month after the end of treatment must be \< 85% to suspend treatment and \> 95% to consider the treatment as safe. The treatment will be interrupted if G3-G4 toxicities and/or biochemical recurrences are recorded within a month in 2 or more pts, otherwise the study will continue with the second phase enrolling another 52 pts for a total of 65 pts. A single fraction SBRT of 24 Gy with the "urethral sparing HDR like" technique will be delivered. Assuming a minimal drop-out, 5 more pts will be enrolled, thus reaching a total number of 70 pts (65 necessary + 5 for any drop-outs). In the absence of worse subsequent toxicity and with a biochemical control comparable to that in the literature as well as historical treatments of our department, the scheme will be considered as safe and effective.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 10, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years after the end of the study
• Access Criteria: Request made to PI prof. Nadia Di Muzio or co-PI Dr. Andrei Fodor, approved by Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) San Raffaele Ethics Committee

Locations

IT (1)