Study of MR-based IGRT for Prostate Cancer (M-basePro)

University Hospital Tuebingen

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: IGRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02724670

M-base Pro 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Radiation

Other group

Description:

IGRT 5x 2Gy/week, total dose: 78 Gy

Treatment:

Radiation: IGRT