Study of MR-based IGRT for Prostate Cancer

Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724670

Acronym

M-basePro

Enrollment

Registered

2016-03-31

Start date

2016-03-31

Completion date

2028-09-30

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.

Detailed description

Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer. Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.

Interventions

RADIATIONIGRT

MR-based IGRT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* histologically proven prostate cancer * indication for curative treatment * ECOG performance scale 0-2 * Informed consent

Exclusion criteria

* contraindications for curative treatment * age\<18year * previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound) * serious comorbidity leading to inability for IGRT (image-guided radiotherapy) * contraindications for MRI (Magnetic Resonance Imaging)

Design outcomes

Primary

Measure	Time frame	Description
G2+gastrointestinal and genitourinary toxicity at 2 years	Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint	Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years

Secondary

Measure	Time frame	Description
Long-term GU-GI toxicity	10 years after treatment	Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years

Countries

Germany

Contacts

Primary ContactArndt-Christian Müller, Dr.

Arndt-Christian.Mueller@med.uni-tuebingen.de497071/2986142

Backup ContactDaniel Zips, Prof.

Daniel.Zips@med.uni-tuebingen.de497071/2982165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026