What is prostate SBRT studying for prostate cancer?

Prostate SBRT is being studied as a one-time high-dose radiation treatment that aims to treat localized prostate cancer while sparing the urethra. Researchers want to evaluate its safety, side effects, cancer control, survival, and impact on quality of life. The study is sponsored by IRCCS San Raffaele and focuses on improving treatment options for prostate cancer patients.

Who may be eligible for this localized prostate carcinoma clinical trial?

Men aged 18 years or older with a confirmed diagnosis of prostate adenocarcinoma and no lymph node or distant metastases may be eligible. Candidates must have acceptable urine flow rates and no prior pelvic radiotherapy. Other health conditions and ability to complete quality of life questionnaires are also considered. Please review eligibility criteria for more details.

Is there any cost to participate in this localized prostate carcinoma clinical trial?

Study-related care, including the radiation treatment and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should consider these possible costs when deciding to join.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

MALE

ID05936736

Single-Center Study of 24 Gy Urethral-Sparing High-Dose-Rate Like Stereotactic Radiotherapy for Localized Prostate Cancer

Led by IRCCS San Raffaele · Updated on 2025-06-08

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new radiation treatment for localized prostate cancer using a single high-dose stereotactic body radiotherapy SBRT session. This trial focuses on delivering 24 Gy in one fraction with a technique that spares the urethra, aiming to reduce side effects while treating the prostate and seminal vesicles. The study is prospective, non-randomized, and conducted at a single center with the goal of assessing safety, toxicity, cancer control, survival, and quality of life over time. The treatment involves implanting fiducials, performing simulation CT and MRI scans, and delivering a single high-dose radiation session similar to high-dose-rate brachytherapy but sparing the urethra. Patients with negative lymph nodes and no distant metastases will receive the radiation dose of 24 Gy in one day. Androgen deprivation therapy ADT will be used for some patients based on risk. Short-term cortisone and alpha-blockers will be given to prevent side effects. The study will enroll up to 70 patients in phases, monitoring toxicity closely before continuing enrollment. Participants will have follow-up visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months. These visits include blood tests for prostate-specific antigen PSA and testosterone, imaging as needed, and quality of life questionnaires covering general health, urinary symptoms, sexual function, and prostate cancer-specific issues. The main outcome is measuring acute toxicity one month after treatment, with longer-term monitoring of cancer control, survival, toxicity, and quality of life through five years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Histological diagnosis of prostate adenocarcinoma, 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) within the past 3 months when recommended
Clinical M0 status confirmed by imaging (PSMA PET/CT and/or bone scan and/or pelvic MRI) within the past 3 months
Acceptable uroflowmetry with peak urine flow preferably 15 ml/s and post void residue 50 cc, or at least 12 ml/s after 3 months of neoadjuvant hormone therapy and alpha-lytic
ECOG performance status 2
No previous pelvic radiotherapy
Ability to complete quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)

You will not qualify if you...

Serious systemic diseases
Psychiatric or other disorders preventing informed consent
Previous invasive cancer except skin cancer unless disease-free for at least 3 years
Lymph node disease (N1)
Evidence of distant metastases (M1)
IPSS questionnaire score > 20 points
Uroflowmetry with maximum basal flow 11 ml/sec and/or post void residue > 100 ml
Concomitant urinary or gastrointestinal inflammatory diseases such as ulcerative colitis or Crohn's disease
Overactive bladder
Inability to implant fiducials
Inability or refusal to place bladder catheter for simulation CT and MRI
Inability to perform simulation MRI
Contraindication to hormonal treatment when indicated
Non-compliance with dose limits established in the treatment plan

Research Team

Andrei Fodor, MD

Nadia Di Muzio, Prof

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