Clinical trial NCT04845503: Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
Official title: Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: University Hospital, Zürich
First posted: 2021-04-15
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Toxicity or Discontinuation of Therapy
timeFrame: Within 1 Year
Secondary outcomes:
measure: Mortality
timeFrame: Within 1 year and within 5 years
measure: Number of Toxicities
timeFrame: Within 1 year and within 5 years after start of radiotherapy
measure: bPFS
timeFrame: 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
measure: Hormone therapy-free Survival
timeFrame: from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant
measure: OS
timeFrame: from start of radiotherapy (day 1) until death or censoring assessed up to 5 years
measure: Quality of life according to EORTC QLQ-C30
timeFrame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
measure: Quality of life according to EORTC QLQ-PR25
timeFrame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
measure: Symptoms and Toxicity
timeFrame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg, Radiation Oncology
Study officials:
References: