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Localized Prostate CarcinomaPRO-FASTNCT05936736

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

A study testing prostate SBRT in people with Localized Prostate Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Localized Prostate Carcinoma
What is being tested?
prostate SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteItaly
Study dates
8 Nov 2023to May 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrei Fodor, MD contact

+390226437634

fodor.andrei@hsr.it

Nadia Di Muzio, Prof contact

+390226437643

dimuzio.nadia@hsr.it

Italy1 site, 1 recruiting

  • San Raffaele Scientific Institute

    Milan, MI, 20132

    Nadia G Di Muzio, Prof, +390226437643, dimuzio.nadia@hsr.it

    Fodor Andrei, M.D., +390226437634, fodor.andrei@hsr.it

    Recruiting

Other trials in Italy

About this study

Official title: 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 (PRO-FAST)

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.

Read the detailed description

This is an interventional prospective non-randomised single-center trial that will enroll, 13 patients for the first phase of the study, according to the optimal design of Simon. The hypothesis is that the proportion of patients free from acute cumulative G3-G4 toxicity (Common Terminology Criteria for Adverse Events-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 patients; otherwise the study will continue with the second phase. Another 52 patients will be added, for a total of 65 patients. The treatment consists in a single fraction of 24 Gy with the "urethral sparing HDR like" technique. Assuming a minimal drop-out, given that the primary endpoint is toxicity one month after treatment, we will enroll 5 more patients in total, thus reaching a total number of 70 patients (65 necessary + 5 for any drop-outs).

In the absence of worse subsequent toxicity, and with biochemical control comparable to that in the literature as well as historical treatments in our Radiation Oncology, the scheme will be considered safe, and the enrollment will continue open label.

Patients with negative lymph nodes and without distant metastases will be enrolled and treated on the prostate/prostate and tumor vesicles (depending on the stage) at a total dose of 24 Gy delivered in a single fraction, sparing the urethra and with a dose distribution similar to high dose rate brachytherapy. Androgen Deprivation Therapy (ADT) will be prescribed according to the guidelines for the stages of the disease.

Short-term cortisone and alpha lytics will be prescribed, for prophylactic purposes. Follow-up visits will be performed at 1, 3, 6,12,18, 24, 36, 48, 60 months with blood tests including prostate specific antigen (PSA) and testosterone (performed every 3 months in the first two years, every 6 months in the next 3 years), imaging, when needed, and quality of life questionnaires: European Organization for Research and Treatment of cancer (EORTC) quality of life questionnaire (QLQ) C30 and QLQ-PR25, International Prostate symptoms score (IPSS), International Index of Erectile Function (IIEF)-5, Expanded Prostate Cancer Index Composite (EPIC)- 26.

Being tested
prostate SBRT
Keywords
Prostate Cancer, Single fraction SBRT, Urethral sparing HDR like, PSMA PET/CT, Organ movement, Radiomics
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prostate SBRTRadiation

    Also called ultrahypofractionation, extreme hypofractionation

    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

Study groups in NCT05936736
Study groupRoleWhat they receive
24 Gy in one fraction, urethral sparing HDR likeExperimentalPatients 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.
Receives: Radiation: prostate SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: one month

Secondary outcomes (12)

  1. Biochemical control

    Biochemical control rate at 1,3 and 5 years by measuring Prostate Specific Antigen-PSA- value which must be below (2+nadir) ng/ml

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

  2. Biochemical relapse

    Biochemical Relapse-Free survival

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

  3. Local Control

    Local Relapse-Free survival

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

  4. Distant Disease Control

    Distant Metastases-Free Survival

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

  5. Survival

    Overall Survival

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

  6. Subacute Toxicity

    Subacute toxicity rated on CTCAE v5.0 scale (see Outcome 1 for details)

    Measured: 3 months

  7. Late Toxicity

    Late toxicity rated on using CTCAE v5.0 scale (see Outcome 1 for details)

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

  8. Incidence of Treatment-Emergent Adverse Events as assessed with general quality of life questionnaires

    Survey with the questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) Quality of life of cancer patients (QLQ C30) which contains 30 questions on patients' quality of life with answers from 1, lowest grade, to 4, highest grade

    Measured: 5 years

  9. Incidence of Treatment-Emergent Adverse Events as assessed with prostate specific quality of life questionnaires

    Survey with the questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) Quality of life of prostate cancer patients (QLQ PR25) which contains 25 questions on patients' quality of life with answers from 1, lowest grade, to 4, highest grade

    Measured: 5 years

  10. Incidence of Treatment-Emergent Adverse Events as assessed with urinary quality of life questionnaires

    Survey with the questionnaire International Prostatic Symptoms Score (IPSS) which has 8 questions with answers rom never (0) to almost every time (5). The score is obtained by summing the answers

    Measured: 5 years

  11. Incidence of Treatment-Emergent Adverse Events as assessed with erectile quality of life questionnaires

    Survey with the questionnaire IIEF-5 (International Index of Erectile Function). The IIEF-5 score is the sum of the ordinal responses to the 5 items, with higher scores indicating no erectile dysfunction and lower scors indicating severe erectile dysfunction.

    Measured: 5 years

  12. Incidence of Treatment-Emergent Adverse Events as assessed with composite quality of life questionnaires

    Survey with the questionnaire EPIC-26 (The Expanded Prostate Cancer Index Composite) a questionnaire designed to measure Quality of Life issues in patients with Prostate cancer, through 13 questions with answers from 1 to 5, with 1 indicating the absence of the problem and 5 indicating an important problem. Lower scores indicate a better outcome

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start8 Nov 2023
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936736
Sponsor's protocol ID
PRO-FAST
Acronym
PRO-FAST
Status last verified
Oct 2026
First submitted
20 Jun 2023
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study (anonymized individual participant data) are available on request from the corresponding author to researchers who provide a methodologically sound proposal. Requests made to the corresponding author will be evaluated by the IRCCS San Raffaele Scientific Institute Ethics Committee.

Publications

  • Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.

    PubMed 27626136

  • Donovan JL, Hamdy FC, Lane JA, Mason M, Metcalfe C, Walsh E, Blazeby JM, Peters TJ, Holding P, Bonnington S, Lennon T, Bradshaw L, Cooper D, Herbert P, Howson J, Jones A, Lyons N, Salter E, Thompson P, Tidball S, Blaikie J, Gray C, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Davis M, Turner EL, Martin RM, Neal DE; ProtecT Study Group*. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1425-1437. doi: 10.1056/NEJMoa1606221. Epub 2016 Sep 14.

    PubMed 27626365

  • Prada PJ, Cardenal J, Blanco AG, Anchuelo J, Ferri M, Fernandez G, Arrojo E, Vazquez A, Pacheco M, Fernandez J. High-dose-rate interstitial brachytherapy as monotherapy in one fraction for the treatment of favorable stage prostate cancer: Toxicity and long-term biochemical results. Radiother Oncol. 2016 Jun;119(3):411-6. doi: 10.1016/j.radonc.2016.04.006. Epub 2016 Apr 22.

    PubMed 27118583

  • Prada PJ, Ferri M, Cardenal J, Blanco AG, Anchuelo J, Diaz de Cerio I, Vazquez A, Pacheco M, Raba I, Ruiz S. High-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. Brachytherapy. 2018 Nov-Dec;17(6):845-851. doi: 10.1016/j.brachy.2018.06.002. Epub 2018 Jul 18.

    PubMed 30030111

  • Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.

    PubMed 12128107

  • Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.

    PubMed 17765406

  • Hall MD, Schultheiss TE, Smith DD, Tseng BP, Wong JY. The impact of increasing dose on overall survival in prostate cancer. Radiat Oncol. 2015 May 21;10:115. doi: 10.1186/s13014-015-0419-3.

    PubMed 25990489

  • Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.

    PubMed 27339115

  • Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.

    PubMed 28296582

  • Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.

    PubMed 27044935

  • Fowler JF, Toma-Dasu I, Dasu A. Is the alpha/beta ratio for prostate tumours really low and does it vary with the level of risk at diagnosis? Anticancer Res. 2013 Mar;33(3):1009-11.

    PubMed 23482774

  • Miralbell R, Roberts SA, Zubizarreta E, Hendry JH. Dose-fractionation sensitivity of prostate cancer deduced from radiotherapy outcomes of 5,969 patients in seven international institutional datasets: alpha/beta = 1.4 (0.9-2.2) Gy. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e17-24. doi: 10.1016/j.ijrobp.2010.10.075. Epub 2011 Feb 15.

    PubMed 21324610

  • Dasu A, Toma-Dasu I. Prostate alpha/beta revisited -- an analysis of clinical results from 14 168 patients. Acta Oncol. 2012 Nov;51(8):963-74. doi: 10.3109/0284186X.2012.719635. Epub 2012 Sep 12.

    PubMed 22966812

  • Katz AJ, Santoro M, Diblasio F, Ashley R. Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. Radiat Oncol. 2013 May 13;8:118. doi: 10.1186/1748-717X-8-118.

    PubMed 23668632

  • King CR, Freeman D, Kaplan I, Fuller D, Bolzicco G, Collins S, Meier R, Wang J, Kupelian P, Steinberg M, Katz A. Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. Radiother Oncol. 2013 Nov;109(2):217-21. doi: 10.1016/j.radonc.2013.08.030. Epub 2013 Sep 20.

    PubMed 24060175

Questions about this trial

What is this clinical trial studying?

A study testing prostate SBRT in people with Localized Prostate Carcinoma, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrei Fodor, MD (+390226437634, fodor.andrei@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936736, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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