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

University Hospital Tuebingen78 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

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.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Müller Arndt-Christian

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

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%

Time frame: 2 years

Secondary Outcomes

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

Time frame: 6 months

Rate of participants achieving local control

In case of PSA progress: No evidence of local recurrence detected by MRI

Time frame: 2, 5, 10 years

Rate of participants achieving regional control

In case of PSA progress: No evidence of regional recurrence detected by MRI

Time frame: 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

Time frame: 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

Time frame: 2, 5, 10 years

Time without secondary treatment "TWIST"

Time without secondary treatment calculated from start of IGRT

Time frame: 2, 5, 10 years

Central Contacts

Silke Theden

CONTACT

+49707183420 silke.theden@med.uni-tuebingen.de

Arndt-Christian Müller

CONTACT

Data from ClinicalTrials.gov

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