Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Prostate Cancer Clinical Trial

— SMILE  

Official title:

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845503
• Other study ID #: SMILE
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 25, 2028

Study information

• Verified date: January 2023
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: March 25, 2028
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• MR-guided Radiotherapy
Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Ludwig-Maximilians - University of Munich, University Hospital, Zürich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased)	Within 1 year and within 5 years
Secondary	Number of Toxicities	Number and severity of urogenital or gastrointestinal toxicity	Within 1 year and within 5 years after start of radiotherapy
Secondary	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
Secondary	Hormone therapy-free Survival	Hormone therapy-free Survival	from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant
Secondary	OS	overall survival	from start of radiotherapy (day 1) until death or censoring assessed up to 5 years
Secondary	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)
Secondary	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)
Secondary	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)