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Prostate CancerFAST-ONENCT07112781

Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Prostate Cancer

A study testing Single Dose Radiotherapy in people with Prostate Cancer, run by Branch Office of "Hadassah Medical Ltd" at 1 site in Russia.

Recruiting

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

Sites and contacts
Official record
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Trial summary

The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Single Dose Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRussia
Study dates
24 Jul 2024to Aug 2027
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

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • Biopsy Gleason score ≤ 7;
  • Up to 6 months of previous hormonal therapy is allowed (but not required);
  • PSA ≤ 20 prior to hormone therapy (if given);
  • No direct evidence of regional or distant metastases after appropriate staging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) / CT)
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  • Age ≥ 18;
  • Performance Status 0-2;
  • International Prostate Symptom Score (IPSS) must be ≤ 15 (alpha blockers allowed)
  • Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or Ultrasound-based volume estimation of prostate gland ≤ 100 cc

Who cannot join

  • Positive lymph nodes or metastatic disease from prostate cancer on imaging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) / CT);
  • Tumour Clinical stage T3 or T4 on MRI;
  • Gleason score > 7;
  • PSA > 20 ng/mL;
  • Previous pelvic radiotherapy;
  • Previous surgery for prostate cancer;
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  • Recent transurethral resection of the prostate (TURP) (less than 3 months);
  • Previous hormonal therapy given for more than 6 months prior to therapy;
  • Prior invasive malignancy unless disease free for a minimum of 3 years;
  • Previous significant urinary obstructive symptoms;
  • Significant psychiatric illness;
  • Ultrasound or CT or MRI estimate of prostate volume > 100 cc;
  • Severe, active co-morbidity.
  • Inability to fulfill all dosimetric criteria for target dose coverage and restrictions for the organs at risk according to study protocol;

Trial locations and contacts

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

Sergey Usychkin, MD contact

+79166840574

s.usychkin@hadassah.moscow

Russia1 site, 1 recruiting
  • The Branch of Hadassah Medical LTD

    Moscow, 121205

    Sergey Usychkin, MD, +79166840574, s.usychkin@hadassah.moscow

    Igor Utyashev, MD, +79265894252, i.utyashev@hadassah.moscow

    Recruiting

Other trials in Russia

About this study

Official title: Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Prostate Cancer Using Special System of Internal and External Immobilization for Target Motion Mitigation

The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland.

Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as low or intermediate risk prostate cancer (Stage T1-T2c and/or Prostate Specific Antigen (PSA) level ≤20 ng/mL and/or Gleason score of ≤7).

Read more

The study will examine the technical feasibility of image-guided volumetrically-modulated arc therapy (VMAT-IGRT) with an emphasis on normal tissue sparing and precision of radiation delivery using dedicated devices (an air-filled endorectal balloon and a Foley catheter) that ensure target immobilization and reproducibility of prostate anatomical localization using a special external patient immobilization system, including patient placement on the patient transfer trolley, which allows patient transfer without removing the endorectal balloon and urinary catheter during all stages of simulation and treatment planning (MR, CT, Positron emission tomography (PET) / CT-simulation) and during the treatment session on the linear accelerator.

Previously untreated patients with localized prostate cancer of the low risk and favorable intermediate risk (NCCN) groups will receive SDRT at a dose of 24 Gy. In patients from the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local escalation of the DIL dose to 30 Gy will be performed.

Patients will be followed up at one week and one month after completion of treatment, then every 3 months for 24 months (+/- 4 weeks), and every 6 months thereafter. Evaluation of early and late adverse events will focus, although not exclusively, on the genitourinary and gastrointestinal toxicity, primarily the rectal toxicity. Serum prostate-specific antigen (PSA) levels will be determined according to the clinical follow-up schedule. Multiparametric magnetic resonance imaging (mpMRI) with intravenous contrast will be performed at baseline and at 6-, 12-, and 24-months post-intervention. Participants of the study will be followed up for at least 2 years after treatment.

Read the detailed description

This study evaluates the clinical outcomes and potential adverse events associated with external beam single-dose radiotherapy (SDRT) using a dedicated internal and external target immobilization system in patients with low- and intermediate-risk localized prostate adenocarcinoma.

The findings from recently published randomized trial demonstrate that five-fraction SBRT is a robust and viable alternative to moderately fractionated radiotherapy for prostate cancer, demonstrating equivalent efficacy with enhanced convenience for patients. The high 5-year biochemical control rates, tolerability of treatment, coupled with the significant advancements in radiotherapy delivery, underscore the potential of Stereotactic Body Radiation Therapy (SBRT) use in prostate cancer treatment.

The feasibility of Single-Dose RadioTherapy (SDRT) in localized prostate cancer was tested in the randomized PROSINT trial comparing 5-session ultra-hypofractionated radiotherapy course with a Single Dose of 24 Gy radiotherapy. The 4-year results of this trial were recently published. The adverse event profile in both comparison groups was exceptionally good, with no severe adverse events of 3 or higher according to the NCI CTCAE v.4.0 scale and similar biochemical tumor response to both treatment regimens.

Patients enrolled in this trial will undergo volumetric intensity modulation arc therapy (VMAT-IGRT) using state-of-the-art dosimetric radiation therapy planning and quality assurance procedures with an emphasis on normal tissue sparing and precision of radiation delivery using dedicated devices that ensure target immobilization and reproducibility of prostate anatomical localization. A special endorectal balloon filled with air will be used for immobilization of the target in the prostate gland and anatomical reproducibility, while a urethral Foley catheter will be used to ensure reproducibility of the urethral position and online tracking of the prostate gland position (during the entire radiotherapy session). The study will also examine the technical feasibility of using a special external patient immobilization system, including patient positioning on a patient transfer trolley, which allows for patient transfer without removing the endorectal balloon and urinary catheter from the table at all stages of pre-radiation preparation (MR, CT, Positron emission tomography (PET) / CT simulation) and during the treatment session on the linear accelerator. Previously untreated patients with localized prostate cancer in the low risk and favorable intermediate risk (NCCN) groups will receive SDRT at a dose of 24 Gy. In patients in the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local dose escalation per DIL to 30 Gy will be performed.

Patients will be followed up at one week and one month after completion of treatment, then every 3 months for 24 months (+/- 4 weeks), and every 6 months thereafter. Evaluation of early and late adverse events will focus, although not exclusively, on the genitourinary and gastrointestinal tracts, primarily the rectum. Serum prostate-specific antigen (PSA) levels will be determined according to the clinical follow-up schedule. Multiparametric magnetic resonance imaging (mpMRI) with intravenous contrast will be performed at baseline and at 6-, 12-, and 24-months post-intervention. The study participants will be followed up for at least 2 years.

Conditions
Prostate Cancer
Being tested
Single Dose Radiotherapy
Keywords
Prostate Cancer, Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Single Dose RadiotherapyRadiation

    Procedure: external-beam radiotherapy (EBRT) on a linear accelerator with a dose 24 Gy in one session using technique of image-guided volumetric intensity modulation arc therapy (VMAT-IGRT) and a set of dedicated devices that ensure target immobilization and reproducibility of prostate anatomical localization during treatment. A special air-filled endorectal balloon will be used for immobilization of the prostate and anatomical reproducibility of organs at risk during treatment. A Foley catheter will be used to ensure reproducibility of the urethral position and online tracking of the prostate gland position during treatment. A special external immobilization system, including patient positioning on a patient transfer trolley, which allows for patient transfer without removing the endorectal balloon and urinary catheter from the table at all stages of pre-radiation preparation (MR, CT, Positron emission tomography (PET) / CT simulation) and during the treatment.

Study groups in NCT07112781
Study groupRoleWhat they receive
Single-Dose Radiotherapy (SDRT)ExperimentalPatients will be treated using image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. Patients will be treated with a single fraction at a prescription dose of 24 Gy. In patients in the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local dose escalation per DIL to 30 Gy will be performed.
Receives: Radiation: Single Dose Radiotherapy

What is being measured

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

  1. Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0

    Assessment of treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0 over a 5 year time frame.

    Measured: 2 years

  2. Concentration of serum PSA

    Changes of serum PSA after treatment

    Measured: 2 years

  3. Biochemical relapse-free survival (bRFS)

    Biochemical relapse-free survival rate (Phoenix Definition)

    Measured: 2 years

Secondary outcomes (3)
  1. Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to measure quality of life

    Quality of life is measured on a scale of 0 to 100, with higher scores representing a higher quality of life.

    Measured: 2 years

  2. International Index of Erectile Function (IIEF) Questionnaire to assess sexual function

    Sexual function is measured on a scale of 0 to 75, with higher scores representing higher sexual function.

    Measured: 2 years

  3. Primary prostate tumor response based on multi-parametric MRI imaging

    Assessment of tumor response based on prostate multi-parametric MRI changes after treatment

    Measured: 2 years

Timeline

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

  1. First posted8 Aug 2025
  2. Study start24 Jul 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112781
Sponsor's protocol ID
FAST-ONE
Acronym
FAST-ONE
Status last verified
Aug 2025
First submitted
2 Aug 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Single Dose Radiotherapy in people with Prostate Cancer, run by Branch Office of "Hadassah Medical Ltd" at 1 site in Russia.

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 10 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 13 Aug 2025. 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 Russia. 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 Sergey Usychkin, MD (+79166840574, s.usychkin@hadassah.moscow), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0 (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Aug 2025.

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