MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)

Prostate Cancer Clinical Trial

— Mbase_HyPro  

Official title:

Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880851
• Other study ID #: Mbase HyPro 2.0
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2019
• Source: University Hospital Tuebingen
• Contact: Silke Theden
• Phone: +49707183420
• Email: silke.theden[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Plan adaptation of Radiation Treatment in case of anatomical changes
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.

Locations

Country	Name	City	State
Germany	Müller Arndt-Christian	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	2 years
Secondary	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	6 months
Secondary	Rate of participants achieving local control	In case of PSA progress: No evidence of local recurrence detected by MRI	2, 5, 10 years
Secondary	Rate of participants achieving regional control	In case of PSA progress: No evidence of regional recurrence detected by MRI	2, 5, 10 years
Secondary	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	2, 5, 10 years
Secondary	Number of Participants with biochemical no evidence of disease "bNED"	biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml	2, 5, 10 years
Secondary	Time without secondary treatment "TWIST"	Time without secondary treatment calculated from start of IGRT	2, 5, 10 years
Secondary	CTC-Proctitis	CTC 4.0	2, 5, 10 years
Secondary	CTC-Incontinence	CTC 4.0	2, 5, 10 years
Secondary	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	2, 5, 10 years
Secondary	Overall survival "OS"	Overall survival is calculated from start of IGRT	2, 5, 10 years