Prostate CancerWARPNCT07591051
Weekly Online CT or MR Adaptive Definitive SBRT for Regionally Metastatic Prostate Cancer
A study testing weekly CT or MR online adaptive definitive SBRT in people with Prostate Cancer, run by University of Zurich at 2 sites in 2 countries.
Trial summary
This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria. Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. 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?
- weekly CT or MR online adaptive definitive SBRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2027to Jan 2033
- 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
- Regionally metastatic prostate cancer (cN1, any T, Gleason 6-10, any PSA) according to NCCN guidelines consisting of ≤ 5 regional lymph node metastases
- Good to moderate performance status (WHO 0-2)
- Written informed consent.
- A PSMA PET and multiparametric MRI is mandatory according to staging guidelines.
- Age ≥ 18 years
Who cannot join
- >5 regional lymph nodes
- Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall)
- Previous radiotherapy to the pelvis or prostate
- Previous radical prostatectomy
- Large body size that would not fit into the MRI-simulator bore
- Presence of distant metastases (i.e. cM1)
Show all 17Show fewer
- Non-regional lymph nodes (M1a):
- Bone metastases (M1b)
- Other sites (M1c)
- Contraindications to CT or MR-adaptive SBRT (e.g., pacemakers, severe claustrophobia).
- Severe comorbidities that may interfere with treatment or follow-up (e.g. inflammatory bowel disease).
- Significant concomitant diseases (e.g. hepatic dysfunction, cardiovascular disease, etc.).
- Inability to follow procedures or insufficient knowledge of project language, inability to give consent.
- Participation in a clinical trial which might influence the results of this project.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Severe genitourinary or gastrointestinal symptoms (e.g. recent urinary retention or diarrhea ≥ grade 3 or obstipation to CTCAE v.6.0).
- Severe urinary symptoms (e.g. IPSS >12 and/or prostate volume > 80 mL)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
University Clinic Heidelberg
Heidelberg, Baden-Würtemberg, 69120
Jürgen Debus
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Matthias Guckenberger
Tiuri Kroese
About this study
Official title: Weekly Online CT or MR Adaptive Definitive SBRT for Regionally Metastatic Prostate Cancer (WARP)
This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria.
Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
Read more
This study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for regionally metastatic prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality.
Weekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population.
A diagnostic high field MRI during radiotherapy, e.g. week 3 is optional.
Follow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).
- Conditions
- Prostate Cancer
- Being tested
- weekly CT or MR online adaptive definitive SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly CT or MR online adaptive definitive SBRTDevice
Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Study | Other | Assessment of weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. Receives: Device: weekly CT or MR online adaptive definitive SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- a successful delivery of CT or MR-informed SBRT per fraction
Feasibility will be assessed by recording whether each fraction of stereotactic body radiation therapy (SBRT), guided by computed tomography (CT) or magnetic resonance (MR) imaging, is successfully delivered according to the planned treatment parameters. Successful delivery is defined as completion of the planned fraction without protocol deviations or technical interruptions. Data will be summarized as the proportion of fractions successfully delivered per patient and overall. Every treatment fraction having passed the point of entry into the adaptive workflow will be analyzed for this endpoint.
Measured: from Day 1 of treatment up to 7 weeks until end of treatment
Safety - Adverse events
The presence of genitourinary or gastrointestinal toxicity of grade ≥ 3 within 1 year after completion of radiotherapy (according to CTCAE v5.0). Treatment-related discontinuation. and Subgroup analyses will be performed for patients with and without regional lymph node metastases (i.e., cN0 versus cN1).
Measured: ≥ 3 months to within 1 year after completion of SBRT
Secondary outcomes (14)
Biochemical progression-free survival
This will be determined from the start of therapy until the occurrence of PSA recurrence according to the Phoenix criteria i.e. post- therapeutic PSA nadir + 2 ng/ml
Measured: from Day 1 up to 5 years after treatment
Castration-resistant free survival
Castration-resistant free survival defined as cancer progression despite low (castrate) levels of testosterone (<50 ng/dL). Cancer progression is defined as:
- Biochemical progression: ≥2 consecutive PSA rises (at least 1 week apart)
- Radiologic progression: appearance of new lesions on imaging
Measured: from Day 1 up to 5 years after treatment
Patients Quality of Life EQ-5D-5L from the European Organisation for Research and Treatment of Cancer
Quality-of-life will be measured using the EQ-5D-5L questionnaire during and after treatment
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: from Day 1 up to end of study until 5 years
Patients Quality of Life QLQ-C30 from the European Organisation for Research and Treatment of Cancer
Quality of life will be measured using the EORTC QLQ-C30 questionnaire. This instrument includes functional scales, symptom scales, and a global health status/quality-of-life scale. All scores are linearly transformed to a 1-4 scale. For functional scales and global health status, higher scores indicate better functioning or quality of life, whereas for symptom scales/items, higher scores indicate greater symptom burden.
Measured: From Day 1 up to end of study (up to 5 years)
Adverse events
Genitourinary and Gastrointestinal toxicity measured with Common Terminology Criteria for Adverse Events (CTCAE)
Measured: from Day 1 until 5 years or end of Study
Patients overall survival
defined from the start of therapy until death or censoring
Measured: from Day 1 until Progression or death whichever comes first until 5 years
Patient overall treatment - Patient treatment workflow duration (time from MRI scan start to completion of treatment)
Patient will be asked from the start and end of MRI scan to start and end of treatment respectively, and for all steps from simulation to treatment delivery individually
Measured: from Day 1 start of therapy, weekly until end of treatment up to 7 weeks
Other Toxicities
Treatment-related toxicities other than the primary toxicity outcomes will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Other Toxicities will be evaluated during SBRT treatment and throughout follow-up for up to 5 years after completion of treatment or until patient death, whichever occurs first. The type, frequency, and severity (grade) of adverse events will be recorded according to CTCAE v5.0 criteria.
Measured: Day 1 of Treatment for up to 5 years or until death whichever comes first
Dosimetry difference
Dosimetry difference of the online adaptive plan compared to the original plan recalculated on the imaging of the day. Dosimetry difference is defined as difference in coverage of the planning target volume (PTV) or of one of the organs at risk e.g. bowel or rectum
Measured: from Day 1 of treatment start until end of treatment up to 7 Weeks
Anatomy changes assessed on magnetic resonance imaging (MRI)
Anatomical changes will be evaluated using serial magnetic resonance imaging (MRI) acquired during treatment and follow-up. Changes in relevant anatomical structures (e.g., target volume and surrounding organs at risk) will be assessed by comparing images obtained at baseline and subsequent imaging time points. Observed anatomical variations will be documented and summarized descriptively.
Measured: from Day 1 of treatment up to 7 weeks
Comparison of Patient treated and not treated
Comparison of number of patients not treated at all/not treated with all planned fractions in the CT or MR-informed workflow compared to those intended to be treated and categorization of patterns of failure within the CT or MR-informed workflow.
Measured: from Day 1 until 5 Years of study or death
Patient compliance
Patient compliance will be measured by tracking a scheduled treatment sessions and adherence to the prescribed treatment protocol, including completion of all required procedures and instructions. Data will be collected throughout the treatment period and summarized as the proportion of scheduled sessions attended and procedures completed, as well as reasons for any missed sessions or deviations from the protocol.
Measured: from Day 1 until 5 Years / end of Study
Patient well being and comfort
Patients will be asked to report their comfort during and after simulation assess with a 0 to 10 numerical rating scales, with 0 representing complete absence of clinical confidence to 10 representing extreme clinical confidence
Measured: from Day 1 of treatment to weekly up to 7 weeks
Physician decision certainty
clinicians will be asked to report their clinical confidence with a 0 to 10 NRS, with 0 representing complete absence of clinical confidence to 10 representing extreme clinical confidence
Measured: from Day1 of treatment to weekly up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria (Supplementary File 2). Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Study chair, Universitätsspital ZürichTiuri Kroese, Principal investigator, University of ZurichMatthias Guckenberger, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591051
- Sponsor's protocol ID
- RAO-24-033
- Acronym
- WARP
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Online CT or MR Adaptive Definitive SBRT for Regionally Metastatic Prostate Cancer (WARP)
- ClinicalTrials.gov ID
- NCT07591051
- Acronym / sponsor ID
- WARP / RAO-24-033
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 15 May 2026 (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.
This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria.
Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
This study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for regionally metastatic prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality.
Weekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population.
A diagnostic high field MRI during radiotherapy, e.g. week 3 is optional.
Follow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria (Supplementary File 2). Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
| Arm | Type | Receives |
|---|---|---|
| Single Group Study | Other | Device: weekly CT or MR online adaptive definitive SBRTAssessment of weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Regionally metastatic prostate cancer (cN1, any T, Gleason 6-10, any PSA) according to NCCN guidelines consisting of ≤ 5 regional lymph node metastases
- Good to moderate performance status (WHO 0-2)
- Written informed consent.
- A PSMA PET and multiparametric MRI is mandatory according to staging guidelines.
- Age ≥ 18 years
Key exclusion criteria (17 listed)
- >5 regional lymph nodes
- Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall)
- Previous radiotherapy to the pelvis or prostate
- Previous radical prostatectomy
- Large body size that would not fit into the MRI-simulator bore
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 |
|---|---|---|
| weekly CT or MR online adaptive definitive SBRTPatients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints. | Device | Single Group Study |
Primary outcome
Feasibility- a successful delivery of CT or MR-informed SBRT per fraction
Time frame: from Day 1 of treatment up to 7 weeks until end of treatment
Feasibility will be assessed by recording whether each fraction of stereotactic body radiation therapy (SBRT), guided by computed tomography (CT) or magnetic resonance (MR) imaging, is successfully delivered according to the planned treatment parameters. Successful delivery is defined as completion of the planned fraction without protocol deviations or technical interruptions. Data will be summarized as the proportion of fractions successfully delivered per patient and overall. Every treatment fraction having passed the point of entry into the adaptive workflow will be analyzed for this endpoint.
Safety - Adverse events
Time frame: ≥ 3 months to within 1 year after completion of SBRT
The presence of genitourinary or gastrointestinal toxicity of grade ≥ 3 within 1 year after completion of radiotherapy (according to CTCAE v5.0). Treatment-related discontinuation. and Subgroup analyses will be performed for patients with and without regional lymph node metastases (i.e., cN0 versus cN1).
14 secondary outcomes
Biochemical progression-free survival
Time frame: from Day 1 up to 5 years after treatment
Castration-resistant free survival
Time frame: from Day 1 up to 5 years after treatment
Patients Quality of Life EQ-5D-5L from the European Organisation for Research and Treatment of Cancer
Time frame: from Day 1 up to end of study until 5 years
Patients Quality of Life QLQ-C30 from the European Organisation for Research and Treatment of Cancer
Time frame: From Day 1 up to end of study (up to 5 years)
Adverse events
Time frame: from Day 1 until 5 years or end of Study
Patients overall survival
Time frame: from Day 1 until Progression or death whichever comes first until 5 years
Patient overall treatment - Patient treatment workflow duration (time from MRI scan start to completion of treatment)
Time frame: from Day 1 start of therapy, weekly until end of treatment up to 7 weeks
Other Toxicities
Time frame: Day 1 of Treatment for up to 5 years or until death whichever comes first
Dosimetry difference
Time frame: from Day 1 of treatment start until end of treatment up to 7 Weeks
Anatomy changes assessed on magnetic resonance imaging (MRI)
Time frame: from Day 1 of treatment up to 7 weeks
Comparison of Patient treated and not treated
Time frame: from Day 1 until 5 Years of study or death
Patient compliance
Time frame: from Day 1 until 5 Years / end of Study
Patient well being and comfort
Time frame: from Day 1 of treatment to weekly up to 7 weeks
Physician decision certainty
Time frame: from Day1 of treatment to weekly up to 7 weeks
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 21 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Matthias Guckenberger study chair
Universitätsspital Zürich
Tiuri Kroese principal investigator
University of Zurich
Matthias Guckenberger principal investigator
University of Zurich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weekly CT or MR online adaptive definitive SBRT in people with Prostate Cancer, run by University of Zurich at 2 sites in 2 countries.
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 5 inclusion and 17 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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.
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 Radiation Oncology Study Office (+41432534308, RAO_akademischesoffice@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- a successful delivery of CT or MR-informed SBRT per fraction (time frame: from Day 1 of treatment up to 7 weeks until end of treatment). 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?
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 21 Aug 2026.