Prostate CancerPhase 1/2NCT03294889
ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer
A Phase 1/2 study testing Stereotactic body radition (SBRT) in people with Prostate Cancer, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic body radition (SBRT)
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 1 Oct 2030
- Phase
- Phase 1/2
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- Histologically confirmed adenocarcinoma of the prostate without small cell features
- Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009
- MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c
- Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
- PSA ≤15 ng/ml
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- WHO performance status 0-1
- International Prostate Symptom Score ≤ 10 (alpha blockers allowed)
- MRI-based volume estimation of prostate gland ≤ 70 cc
- Patient agrees not to father a child during trial treatment and during 6 months thereafter
Who cannot join
- Tumor clinical stage cT3a-3b or T4
- Evidence of T3a, T3b or T4 disease as assessed by MRI
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies.
- Significant tumor on the transitional zone as assessed by MRI
- Gleason at biopsy ≥ 4+3
- Androgen deprivation therapy or products known to affect PSA levels
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- Impossibility to implant Calypso beacons
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer
- Prior pelvic radiotherapy
- Previous surgery for prostate cancer
- Previous transurethral resection of the prostate (TURP) (< 12 weeks before registration)
- Hip prosthesis
- Severe or active co-morbidity likely to impact on the advisability of SBRT
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva, 1205
Thomas Zilli, MD, +41 79 55 32 563, thomas.zilli@hcuge.ch
Laurence Zulianello, PhD, + 41 22 372 7205, laurence.zulianello@hcuge.ch
About this study
Official title: ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.
Read the detailed description
Total dose and dose per fraction play an important role in the curative treatment of prostate cancer with radiotherapy (RT). Modern image guided external RT allows safe dose escalation of prostate cancer. There are strong radiobiological and clinical considerations that suggest that treatment with a small number of large fractions (hypofractionation) may increase the therapeutic ratio of RT for prostate cancer by increasing the tumor cell killing effect with relatively less toxic effect on the surrounding late responding normal tissues compared to conventional fractionation.
The question of how far can the number of fractions with SBRT be reduced is an exciting research matter with an undoubtful goal, face the challenge of assessing the potential for cure of prostate cancer patients with a single and unique fraction of high dose irradiation similar to what is already undertaken with radiosurgery against brain, lung, and liver targets.
We hypothesize that an ultra-hypofractionated single-dose SBRT employing state of the art of image-guided RT techniques may be feasible, with a safe toxicity profile and an optimal long-term tumor control. Hence, a prospective phase I/II clinical trial will be initiated in prostate cancer patients with a localized disease to validate this treatment schedule as an alternative to normofractionated/moderate hypofractionated RT schedules to be tested in a second time in a phase III trial.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic body radition (SBRT)
- Keywords
- Prostate cancer, Stereotactic body radiation therapy, Calypso® beacon system
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radition (SBRT)Radiation
Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system.
- 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles
- 17 Gy in a single fraction to the urethra planning-risk volume (PRV)
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Toxicity will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I).
Measured: 3 months
Progression free survival (PFS)
The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden
- Responsible party
- Principal investigator, Thomas Zilli, University Hospital, Geneva
- Investigators
- Thomas Zilli, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294889
- Sponsor's protocol ID
- 2017-01236
- Other IDs
- 2017
- Status last verified
- May 2020
- First submitted
- 22 Sep 2017
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zilli T, Franzese C, Guckenberger M, Giaj-Levra N, Mach N, Achard V, Vial N, McDonald A, Alongi F, Scorsetti M, Constantin G, Bertaut A, Miralbell R. Single-Fraction Stereotactic Body Radiotherapy for Localized Prostate Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Jun 18:e261886. doi: 10.1001/jamaoncol.2026.1886. Online ahead of print.
PubMed 42313395Zilli T, Scorsetti M, Zwahlen D, Franzese C, Forster R, Giaj-Levra N, Koutsouvelis N, Bertaut A, Zimmermann M, D'Agostino GR, Alongi F, Guckenberger M, Miralbell R. ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial. Radiat Oncol. 2018 Sep 4;13(1):166. doi: 10.1186/s13014-018-1112-0.
PubMed 30180867
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
- ClinicalTrials.gov ID
- NCT03294889
- Acronym / sponsor ID
- 2017-01236
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Stereotactic body radiation therapy, Calypso® beacon system
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, University of Zurich, Kantonsspital Graubünden
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.
Detailed description
Total dose and dose per fraction play an important role in the curative treatment of prostate cancer with radiotherapy (RT). Modern image guided external RT allows safe dose escalation of prostate cancer. There are strong radiobiological and clinical considerations that suggest that treatment with a small number of large fractions (hypofractionation) may increase the therapeutic ratio of RT for prostate cancer by increasing the tumor cell killing effect with relatively less toxic effect on the surrounding late responding normal tissues compared to conventional fractionation.
The question of how far can the number of fractions with SBRT be reduced is an exciting research matter with an undoubtful goal, face the challenge of assessing the potential for cure of prostate cancer patients with a single and unique fraction of high dose irradiation similar to what is already undertaken with radiosurgery against brain, lung, and liver targets.
We hypothesize that an ultra-hypofractionated single-dose SBRT employing state of the art of image-guided RT techniques may be feasible, with a safe toxicity profile and an optimal long-term tumor control. Hence, a prospective phase I/II clinical trial will be initiated in prostate cancer patients with a localized disease to validate this treatment schedule as an alternative to normofractionated/moderate hypofractionated RT schedules to be tested in a second time in a phase III trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- Histologically confirmed adenocarcinoma of the prostate without small cell features
- Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009
- MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c
- Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
Key exclusion criteria (14 listed)
- Tumor clinical stage cT3a-3b or T4
- Evidence of T3a, T3b or T4 disease as assessed by MRI
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies.
- Significant tumor on the transitional zone as assessed by MRI
- Gleason at biopsy ≥ 4+3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radition (SBRT)Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system. * 19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles * 17 Gy in a single fraction to the urethra planning-risk volume (PRV) | Radiation | – |
Primary outcome
Clinical performance
Time frame: 3 months
Toxicity will be evaluated using Grade ≥ 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I).
Progression free survival (PFS)
Time frame: 3 years
The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 42313395Zilli T, Franzese C, Guckenberger M, Giaj-Levra N, Mach N, Achard V, Vial N, McDonald A, Alongi F, Scorsetti M, Constantin G, Bertaut A, Miralbell R. Single-Fraction Stereotactic Body Radiotherapy for Localized Prostate Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Jun 18:e261886. doi: 10.1001/jamaoncol.2026.1886. Online ahead of print.
- Derived from this study: PubMed 30180867Zilli T, Scorsetti M, Zwahlen D, Franzese C, Forster R, Giaj-Levra N, Koutsouvelis N, Bertaut A, Zimmermann M, D'Agostino GR, Alongi F, Guckenberger M, Miralbell R. ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial. Radiat Oncol. 2018 Sep 4;13(1):166. doi: 10.1186/s13014-018-1112-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Zilli, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic body radition (SBRT) in people with Prostate Cancer, run by University Hospital, Geneva at 1 site in Switzerland.
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 14 May 2020. 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 Switzerland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thomas Zilli, MD (+41 79 55 32 563, Thomas.Zilli@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03294889, which also lists 2 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 14 May 2020.