Prostate CancerMbase_HyProNCT03880851
MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
A study testing Plan adaptation of Radiation Treatment in case of anatomical changes in people with Prostate Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Plan adaptation of Radiation Treatment in case of anatomical changes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- biopsy-proven prostate cancer with indication for RT
- cT1b-cT3a cN0 cM0
- ECOG Performance score 0-2
- IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
- age>18 years
- Informed consent
Who cannot join
- not fulfilled inclusion criteria
- contraindication against curative RT
- age<18 years
- previous pelvic radiotherapy or planned pelvic radiotherapy
- comorbidities interfering with image-guided radiotherapy
- contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
- prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate
Trial locations and contacts
1 site in 1 country.
Arndt-Christian Müller contact
Germany1 site, 1 recruiting
- Recruiting
Müller Arndt-Christian
Tübingen, 72076
Arndt-Christian Müller, 070712986143, arndt-christian.mueller@med.uni-tuebingen.de
About this study
Official title: Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.
Read the detailed description
IGRT-schedule: 20 fractions to a total dose of 60 Gy
Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).
Treatment at MR-Linac allowed
- Conditions
- Prostate Cancer
- Being tested
- Plan adaptation of Radiation Treatment in case of anatomical changes
- Keywords
- hypofractionation, MR-based IGRT, Mbase HyPro
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan adaptation of Radiation Treatment in case of anatomical changesRadiation
Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated image-guided radiotherapy | Other | Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed.
Weekly MRI are used to estimate volume/deformation changes of OAR and target volume.
Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy. Receives: Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
Measured: 2 years
Secondary outcomes (10)
Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT
Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment
Measured: 6 months
Rate of participants achieving local control
In case of PSA progress: No evidence of local recurrence detected by MRI
Measured: 2, 5, 10 years
Rate of participants achieving regional control
In case of PSA progress: No evidence of regional recurrence detected by MRI
Measured: 2, 5, 10 years
Rate of participants achieving Distant-metastasis-free survival "DMFS"
No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET
Measured: 2, 5, 10 years
Number of Participants with biochemical no evidence of disease "bNED"
biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml
Measured: 2, 5, 10 years
Time without secondary treatment "TWIST"
Time without secondary treatment calculated from start of IGRT
Measured: 2, 5, 10 years
CTC-Proctitis
CTC 4.0
Measured: 2, 5, 10 years
CTC-Incontinence
CTC 4.0
Measured: 2, 5, 10 years
Progression-free survival "PFS"
progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT
Measured: 2, 5, 10 years
Overall survival "OS"
Overall survival is calculated from start of IGRT
Measured: 2, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start23 Jan 2019
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (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 Hospital TuebingenThe 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
- Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arndt-Christian Mueller, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880851
- Sponsor's protocol ID
- Mbase HyPro 2.0
- Acronym
- Mbase_HyPro
- Status last verified
- Mar 2019
- First submitted
- 11 Feb 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03880851
- Acronym / sponsor ID
- Mbase_HyPro / Mbase HyPro 2.0
- Conditions
- Prostate Cancer
- Keywords
- hypofractionation, MR-based IGRT, Mbase HyPro
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 19 Mar 2019 (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.
Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.
Detailed description
IGRT-schedule: 20 fractions to a total dose of 60 Gy
Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).
Treatment at MR-Linac allowed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated image-guided radiotherapy | Other | Radiation: Plan adaptation of Radiation Treatment in case of anatomical changesHypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed. Weekly MRI are used to estimate volume/deformation changes of OAR and target volume. Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- biopsy-proven prostate cancer with indication for RT
- cT1b-cT3a cN0 cM0
- ECOG Performance score 0-2
- IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
- age>18 years
Key exclusion criteria (7 listed)
- not fulfilled inclusion criteria
- contraindication against curative RT
- age<18 years
- previous pelvic radiotherapy or planned pelvic radiotherapy
- comorbidities interfering with image-guided radiotherapy
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 |
|---|---|---|
| Plan adaptation of Radiation Treatment in case of anatomical changesImage guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes. | Radiation | Hypofractionated image-guided radiotherapy |
Primary outcome
Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
Time frame: 2 years
Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
10 secondary outcomes
Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT
Time frame: 6 months
Rate of participants achieving local control
Time frame: 2, 5, 10 years
Rate of participants achieving regional control
Time frame: 2, 5, 10 years
Rate of participants achieving Distant-metastasis-free survival "DMFS"
Time frame: 2, 5, 10 years
Number of Participants with biochemical no evidence of disease "bNED"
Time frame: 2, 5, 10 years
Time without secondary treatment "TWIST"
Time frame: 2, 5, 10 years
CTC-Proctitis
Time frame: 2, 5, 10 years
CTC-Incontinence
Time frame: 2, 5, 10 years
Progression-free survival "PFS"
Time frame: 2, 5, 10 years
Overall survival "OS"
Time frame: 2, 5, 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Arndt-Christian Müller contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plan adaptation of Radiation Treatment in case of anatomical changes in people with Prostate Cancer, run by University Hospital Tuebingen 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silke Theden (+49707183420, silke.theden@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2 (time frame: 2 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 20 Mar 2019.