SMILE: Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Recruiting

CT.gov ID

NCT04845503

Collaborator

Ludwig-Maximilians - University of Munich (Other), University Hospital, Zürich (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: MR-guided Radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Actual Study Start Date :

Mar 25, 2021

Anticipated Primary Completion Date :

Mar 25, 2023

Anticipated Study Completion Date :

Mar 25, 2028

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: MR-guided Radiotherapy (5 x 7,5 Gy)

5 x 7,5 Gy prescribed on the PTV

Radiation: MR-guided Radiotherapy

Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Heidelberg, Radiation Oncology	Heidelberg		Germany	69120

Sponsors and Collaborators

University Hospital Heidelberg
Ludwig-Maximilians - University of Munich
University Hospital, Zürich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juergen Debus, Medical Director RadioOncology, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT04845503

Other Study ID Numbers:

SMILE

First Posted:

Apr 15, 2021

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 15, 2021