10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer.
Freddie C Hamdy, Jenny L Donovan, J Athene Lane...
https://pubmed.ncbi.nlm.nih.gov/27626136Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID05936736
24 Gy in One Fraction Urethral-sparing High-Dose-Rate Like Stereotactic Body Radiotherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study
Led by IRCCS San Raffaele · Updated on 2025-06-08
70
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 1 day
Participants receive a single fraction of high-dose stereotactic body radiotherapy (SBRT) to the prostate and seminal vesicles, sparing the urethra, performed in one day including fiducial implantation and radiation delivery. Androgen Deprivation Therapy (ADT) may be given according to disease stage.
1 treatment visit (in-person)
Follow-up
Duration - Up to 5 years
Participants attend follow-up visits for monitoring acute and late toxicities, biochemical control, imaging as needed, and quality of life assessments including blood tests and questionnaires over 5 years.
Visits at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months; blood tests every 3 months for 2 years, then every 6 months for 3 years
Trial Site Locations
Total: 1 location
1
San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Actively Recruiting
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Research Team
A
Andrei Fodor, MD
N
Nadia Di Muzio, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
J L Donovan, F C Hamdy, J A Lane...
https://pubmed.ncbi.nlm.nih.gov/27626365High-dose-rate interstitial brachytherapy as monotherapy in one fraction for the treatment of favorable stage prostate cancer: Toxicity and long-term biochemical results.
Pedro J Prada, Juan Cardenal, Ana García Blanco...
https://pubmed.ncbi.nlm.nih.gov/27118583High-dose-rate interstitial brachytherapy as monotherapy in one fraction of 20.5 Gy for the treatment of localized prostate cancer: Toxicity and 6-year biochemical results.
Pedro J Prada, María Ferri, Juan Cardenal...
https://pubmed.ncbi.nlm.nih.gov/30030111Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial.
Alan Pollack, Gunar K Zagars, George Starkschall...
https://pubmed.ncbi.nlm.nih.gov/12128107Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer.
Deborah A Kuban, Susan L Tucker, Lei Dong...
https://pubmed.ncbi.nlm.nih.gov/17765406The impact of increasing dose on overall survival in prostate cancer.
Matthew D Hall, Timothy E Schultheiss, David D Smith...
https://pubmed.ncbi.nlm.nih.gov/25990489Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.
David Dearnaley, Isabel Syndikus, Helen Mossop...
https://pubmed.ncbi.nlm.nih.gov/27339115Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer.
Charles N Catton, Himu Lukka, Chu-Shu Gu...
https://pubmed.ncbi.nlm.nih.gov/28296582Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer.
W Robert Lee, James J Dignam, Mahul B Amin...
https://pubmed.ncbi.nlm.nih.gov/27044935