Prostate CancerHypoF-SBRTNCT06330909
Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt
A study testing Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT and Radiotherapy (RT) Arm B - IMRT/IGRT in people with Prostate Cancer, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. 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?
- Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT and Radiotherapy (RT) Arm B - IMRT/IGRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2022to Feb 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
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- Primary localized PCa (cN0 and cM0 in mpMRI and PSMA PET):
- high- or very high-risk according to NCCN v2.2021 (see 20.3) OR
- unfavorable intermediate-risk disease according to NCCN v2.2021 (see 20.3)
- Signed, written informed consent for HypoFocal-SBRT study
- Age > 18 years
Show all 10Show fewer
- Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
- ECOG Performance score 0 or 1
- IPSS Score ≤15
- Prostate volume ≤75 ml at RT planning
Who cannot join
- Evidence of neuroendocrine tumor cells
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy approaches to the prostate
- Time gap between the beginning of ADT and conduction of mpMRI and PSMA PET scans is >1 month
- Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and/or PSMA PET/CT
Show all 23Show fewer
- Evidence of metastatic disease (cM+) in mpMRI and/or PSMA PET/CT
- Evidence of cT4 disease in mpMRI or PSMA PET/CT
- PSA >30 ng/ml prior to starting ADT
- Expected patient survival <5 years
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
- Contraindication to undergo a mpMRI scan
- Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
- Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
- Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
- Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
- In mpMRI and PSMA PET/CT or PSMA PET/MRI scans no visible tumor
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- Known or persistent abuse of medication, drugs or alcohol
- Patients expected to have severe set up problems
- Dose constraints for organs at risk cannot be adhered to
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medical Center - University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Image-guided Focal Dose Escalation in Patients With Primary Prostate Cancer Treated With Primary External Beam Hypofractionated Stereotactic Radiation Therapy (HypoFocal-SBRT) - a Prospective, Multicenter, Randomized Phase III Study
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes.
Read the detailed description
Prostate cancer (PCa) is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy (RT) is a main treatment option. Conventional RT for patients with primary PCa aims at delivering a homogeneous dose to the entire prostatic gland. However, recent studies proved that modern medical imaging is able to detect accurately the intraprostatic tumour mass (ITM). Consequently, RT concepts for PCa have an imminent need to be rectified in order to individualize the RT strategy by considering the individual tumor localization. In addition, the radiobiological characteristics of the major organs at risk, the rectum and urinary bladder / urethra, as well as of the PCa itself speak for clear advantages of hypofractionated radiation therapy. High-precision stereotactic body radiation therapy (SBRT) significantly shortens the duration of treatment, with clear implications for quality of life and socio-economic aspects.
The aim of this prospective, randomized, multicenter phase III study is the personalization of RT for patients with primary PCa based on individual tumor geometry derived from modern imaging techniques (mpMRI and PSMA-PET/CT). In the experimental (arm A) simultaneous RT dose escalation to the ITM will be performed under strict adherence to the organs at risks' dose constraints by using SBRT (ultra-hypofractionated radiation therapy) in a shorter treatment time (5 fractions vs. 20 fractions). In the control arm (arm B) the entire prostatic gland will receive a homogeneous moderately hypofractionated RT according to the current guidelines. RFS after RT (calculated from randomization) will be assessed as the primary endpoint as well as toxicities and patient reported quality of life as secondary endpoints. For the patients in the experimental arm we expect a significant benefit in relapse free survival (from 80% to 90% at 5 years). The improvement in relapse free survival could increase the metastatic free survival, prostate cancer survival and overall survival in high risk PCa patients. Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact. In parallel a translational research program will address the identification of novel biomarkers/bio-imaging-markers predictive for outcome after RT. Furthermore, involvement of patient representatives includes information about the studies status and contributes to patient empowerment. These aspects will facilitate the evolution from an individualized RT to a personalized RT.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT, Radiotherapy (RT) Arm B - IMRT/IGRT
- Keywords
- Prostate Cancer, HypoFocal, HypoFocal-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.
Radiotherapy (RT) Arm A - IMRT/IGRT/SBRTRadiation
Also called Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT), Stereotactic Body Radiation Therapy (SBRT)
technique: IMRT/IGRT/SBRT
The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts.
Radiotherapy (RT) Arm B - IMRT/IGRTRadiation
Also called Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT)
technique: IMRT/IGRT
Moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - IMRT/IGRT/SBRT | Experimental | Prostate and seminal vesicles RT with 30 Gy in 6 Gy / fraction; prostate RT with 35 Gy in 7 Gy / fraction including a simultaneous integrated boost (SIB) on the intraprostatic tumour mass (ITM) with 40- 42 Gy in 8 - 8.4 Gy / fraction.
If the boost volume is ≥10 ml and/ or ≥ 1/3 of the prostate, the SIB on the ITM has to be restrained to 40 Gy in 8 Gy / fraction. SBRT will be performed twice a week, with at least 2 days between two RT fractions, 5 fractions in 3 weeks (technique: IMRT/IGRT/SBRT). Receives: Radiation: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT |
| Arm B - IMRT/IGRT | Active comparator | Prostate and seminal vesicles RT with 46.4 Gy in 2.32 Gy per fraction, prostate RT with 60 and 62 Gy in 3 and 3.1 Gy per fraction for unfavorable intermediate-risk and high-risk patients, respectively, 20 fractions, 5 fractions /week, (technique: IMRT/IGRT). Receives: Radiation: Radiotherapy (RT) Arm B - IMRT/IGRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
Primary endpoint is relapse free survival (RFS), defined as time from randomization to relapse or death. Relapse free survival times will be censored at the time see last alive without relapse. Analysis will be conducted after finalization of the study.
Measured: 7 years
Secondary outcomes (10)
Time to local failure after randomization
Time to local failure after randomization. Local recurrences have to be confirmed by biopsy
Measured: 7 years
Metastatic free survival after randomization
Metastatic free survival after randomization (all metastases have to be confirmed by imaging, preferably PSMA-PET/CT or mpMR imaging)
Measured: 7 years
Overall (OS) and prostate cancer specific (PCSS) survival after randomization
Overall (OS) and prostate cancer specific (PCSS) survival after randomization
Measured: 7 years
Time to biochemical failure (phoenix definition) after randomization
Time to biochemical failure (phoenix definition) after randomization
Measured: 7 years
Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26)
Patient reported acute quality of life (QOL). Acute QOL will be assessed with the Expanded Prostate Index Composite-26 (EPIC-26) Short Form and International Prostate Symptom Score (IPSS) questionnaires at the following time points: before treatment (baseline), last day of treatment, FU visits at months 3 and 6 after randomization
Measured: at months 3 and 6 after randomization
Patient reported late quality of life (QOL)
Patient reported late quality of life (QOL). Late QOL will be assessed with the Expanded Prostate Index Composite-26 (EPIC-26) Short Form and International Prostate Symptom Score (IPSS) questionnaires at the following time points: FU visits at months 9,12,15,18 21, 24, 30, 36, 42, 48 and months 54, 60, 66, 72, 78, 84 up to 90 after randomization
Measured: up to 90 after randomization
Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria
Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria
Measured: up to 3 months
Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria
Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria
Measured: 7 years
Dose constraints and prescription doses / recruited patients
Feasibility and adherence to dose constraints by measuring the ratio between: number of patients with fulfilled dose constraints and prescription doses / recruited patients
Measured: 7 years
Characterization of safety: adverse events
Characterization of safety: adverse events
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Aug 2022
- Primary completionAug 2025 (estimated)
- Study completionFeb 2030 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy. Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention).
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. med. Anca-Ligia Grosu, University Hospital Freiburg
- Investigators
- Anca-Ligia Grosu, Prof., Study chair, Medical Center- University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330909
- Sponsor's protocol ID
- P003103
- Other IDs
- DRKS00022915
- Acronym
- HypoF-SBRT
- Status last verified
- Mar 2024
- First submitted
- 23 May 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Focal Dose Escalation in Patients With Primary Prostate Cancer Treated With Primary External Beam Hypofractionated Stereotactic Radiation Therapy (HypoFocal-SBRT) - a Prospective, Multicenter, Randomized Phase III Study
- ClinicalTrials.gov ID
- NCT06330909
- Acronym / sponsor ID
- HypoF-SBRT / P003103
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, HypoFocal, HypoFocal-SBRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 26 Mar 2024 (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.
Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes.
Detailed description
Prostate cancer (PCa) is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy (RT) is a main treatment option. Conventional RT for patients with primary PCa aims at delivering a homogeneous dose to the entire prostatic gland. However, recent studies proved that modern medical imaging is able to detect accurately the intraprostatic tumour mass (ITM). Consequently, RT concepts for PCa have an imminent need to be rectified in order to individualize the RT strategy by considering the individual tumor localization. In addition, the radiobiological characteristics of the major organs at risk, the rectum and urinary bladder / urethra, as well as of the PCa itself speak for clear advantages of hypofractionated radiation therapy. High-precision stereotactic body radiation therapy (SBRT) significantly shortens the duration of treatment, with clear implications for quality of life and socio-economic aspects.
The aim of this prospective, randomized, multicenter phase III study is the personalization of RT for patients with primary PCa based on individual tumor geometry derived from modern imaging techniques (mpMRI and PSMA-PET/CT). In the experimental (arm A) simultaneous RT dose escalation to the ITM will be performed under strict adherence to the organs at risks' dose constraints by using SBRT (ultra-hypofractionated radiation therapy) in a shorter treatment time (5 fractions vs. 20 fractions). In the control arm (arm B) the entire prostatic gland will receive a homogeneous moderately hypofractionated RT according to the current guidelines. RFS after RT (calculated from randomization) will be assessed as the primary endpoint as well as toxicities and patient reported quality of life as secondary endpoints. For the patients in the experimental arm we expect a significant benefit in relapse free survival (from 80% to 90% at 5 years). The improvement in relapse free survival could increase the metastatic free survival, prostate cancer survival and overall survival in high risk PCa patients. Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact. In parallel a translational research program will address the identification of novel biomarkers/bio-imaging-markers predictive for outcome after RT. Furthermore, involvement of patient representatives includes information about the studies status and contributes to patient empowerment. These aspects will facilitate the evolution from an individualized RT to a personalized RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy. Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention).
| Arm | Type | Receives |
|---|---|---|
| Arm A - IMRT/IGRT/SBRT | Experimental | Radiation: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRTProstate and seminal vesicles RT with 30 Gy in 6 Gy / fraction; prostate RT with 35 Gy in 7 Gy / fraction including a simultaneous integrated boost (SIB) on the intraprostatic tumour mass (ITM) with 40- 42 Gy in 8 - 8.4 Gy / fraction. If the boost volume is ≥10 ml and/ or ≥ 1/3 of the prostate, the SIB on the ITM has to be restrained to 40 Gy in 8 Gy / fraction. SBRT will be performed twice a week, with at least 2 days between two RT fractions, 5 fractions in 3 weeks (technique: IMRT/IGRT/SBRT). |
| Arm B - IMRT/IGRT | Active comparator | Radiation: Radiotherapy (RT) Arm B - IMRT/IGRTProstate and seminal vesicles RT with 46.4 Gy in 2.32 Gy per fraction, prostate RT with 60 and 62 Gy in 3 and 3.1 Gy per fraction for unfavorable intermediate-risk and high-risk patients, respectively, 20 fractions, 5 fractions /week, (technique: IMRT/IGRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- Primary localized PCa (cN0 and cM0 in mpMRI and PSMA PET):
- Signed, written informed consent for HypoFocal-SBRT study
- Age > 18 years
- Previously conducted PSMA-PET/CT and mpMRI scans or PSMA-PET/MR, fulfilling standard requirements for PCa (see also 6.5)
Key exclusion criteria (23 listed)
- Evidence of neuroendocrine tumor cells
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy approaches to the prostate
- Time gap between the beginning of ADT and conduction of mpMRI and PSMA PET scans is >1 month
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 |
|---|---|---|
| Radiotherapy (RT) Arm A - IMRT/IGRT/SBRTAlso: Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT), Stereotactic Body Radiation Therapy (SBRT)technique: IMRT/IGRT/SBRT The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. | Radiation | Arm A - IMRT/IGRT/SBRT |
| Radiotherapy (RT) Arm B - IMRT/IGRTAlso: Intensity modulated radiotherapy (IMRT), Image guided radiotherapy (IGRT)technique: IMRT/IGRT Moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. | Radiation | Arm B - IMRT/IGRT |
Primary outcome
Relapse free survival
Time frame: 7 years
Primary endpoint is relapse free survival (RFS), defined as time from randomization to relapse or death. Relapse free survival times will be censored at the time see last alive without relapse. Analysis will be conducted after finalization of the study.
10 secondary outcomes
Time to local failure after randomization
Time frame: 7 years
Metastatic free survival after randomization
Time frame: 7 years
Overall (OS) and prostate cancer specific (PCSS) survival after randomization
Time frame: 7 years
Time to biochemical failure (phoenix definition) after randomization
Time frame: 7 years
Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26)
Time frame: at months 3 and 6 after randomization
Patient reported late quality of life (QOL)
Time frame: up to 90 after randomization
Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria
Time frame: up to 3 months
Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria
Time frame: 7 years
Dose constraints and prescription doses / recruited patients
Time frame: 7 years
Characterization of safety: adverse events
Time frame: 7 years
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 26 Mar 2024.
- 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.
Anca-Ligia Grosu, Prof. study chair
Medical Center- University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT and Radiotherapy (RT) Arm B - IMRT/IGRT in people with Prostate Cancer, run by University Hospital Freiburg at 1 site in Germany.
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 23 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 26 Mar 2024. 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 Germany. 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 Sabine Schneider-Fuchs, DR (+4976127074040, sabine.schneider-fuchs@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (time frame: 7 years). 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 26 Mar 2024.