Prostate Cancer
Conditions
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.
Interventions
RADIATIONMR-guided Radiotherapy
Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks
Sponsors
University Hospital Heidelberg
Ludwig-Maximilians - University of Munich
University Hospital, Zürich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity or Discontinuation of Therapy | Within 1 Year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormone therapy-free Survival | from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant | Hormone therapy-free Survival |
| OS | from start of radiotherapy (day 1) until death or censoring assessed up to 5 years | overall survival |
| Mortality | Within 1 year and within 5 years | Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased) |
| Number of Toxicities | Within 1 year and within 5 years after start of radiotherapy | Number and severity of urogenital or gastrointestinal toxicity |
| bPFS | 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 | biochemical progression free survival |
| Quality of life according to EORTC QLQ-PR25 | 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-C30 | from start of radiotherapy (day 1) until end of follow-up (up to 5 years) | Quality of life according to EORTC QLQ-C30 |
| Symptoms and Toxicity | from start of radiotherapy (day 1) until end of follow-up (up to 5 years) | Symptoms and Toxicity according to NCI CTCAE (Rate) |
Countries
Germany
Outcome results
None listed