Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Study Overview
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Brief Summary
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As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.

Official Title
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Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: MR-guided Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml) IPSS (International Prostate Symptom Score) max. 12 Prostate volume <80cm³ Karnofsky index ≥ 70% Age ≥ 18 years Patient information provided and written consent Ability of the patient to give consent Exclusion Criteria: Previous radiotherapy in the pelvis Previous local therapy of the prostate lymphogenic metastasis Stage IV (distant metastases) Contraindication to MRI Simultaneous participation in another clinical study which could influence results of either of the respective study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-guided Radiotherapy (5 x 7,5 Gy)<br>5 x 7,5 Gy prescribed on the PTV | Radiation: MR-guided Radiotherapy<br>* Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity or Discontinuation of Therapy | One of the the following events are counted as an Event (Number of Participants affected): any urogenital or gastrointestinal grade ≥ 2 toxicity within one year after the start of RT (according to NCI CTCAE Version 5.0) Discontinuation of therapy, with a connection to the study treatment | Within 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased) | Within 1 year and within 5 years | 
| Number of Toxicities | Number and severity of urogenital or gastrointestinal toxicity | Within 1 year and within 5 years after start of radiotherapy | 
| bPFS | biochemical progression free survival | from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years | 
| Hormone therapy-free Survival | Hormone therapy-free Survival | from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant | 
| OS | overall survival | from start of radiotherapy (day 1) until death or censoring assessed up to 5 years | 
| Quality of life according to EORTC QLQ-C30 | Quality of life according to EORTC QLQ-C30 | from start of radiotherapy (day 1) until end of follow-up (up to 5 years) | 
| Quality of life according to EORTC QLQ-PR25 | Quality of life according to EORTC QLQ-PR25 | from start of radiotherapy (day 1) until end of follow-up (up to 5 years) | 
| Symptoms and Toxicity | Symptoms and Toxicity according to NCI CTCAE (Rate) | from start of radiotherapy (day 1) until end of follow-up (up to 5 years) |