Clinical trial NCT04896801: MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Official title: Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: MR-guided radiotherapy
Stereotactic body radiotherapy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 132
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: The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 y
* Histologically confirmed prostate adenocarcinoma
* Low risk: cT1c-T2a, Gleason score 6, PSA \< 10ng/mL
* Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, \< 50% positive biopsy cores)
* Unfavorable intermediate risk: \> 1 intermediate risk factor, Gleason 4+3, \> 50% positive biopsy cores)
* Limited high risk: cT3a with PSA \< 40ng/mL or cT2a-c with a Gleason score \> 7 and/or a PSA \> 20ng/mL but \< 40ng/mL
* World Health Organization performance score 0-2
* Written informed consent

Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL

Exclusion Criteria:

* Transurethral resection (TUR) \< 3months before SBRT
* International Prostate Symptom Score (IPSS) \> 19
* Prostate volume \> 100cc on transrectal ultrasound (TRUS)
* Stage cT3b-T4
* N1 disease (clinically or pathologically)
* M1 disease (clinically or pathologically)
* PSA \> 40ng/mL
* inflammatory bowel disease
* immunosuppressive medications
* prior pelvic RT
* contra-indications for MRI

Primary outcomes:
measure: Acute toxicity according to CTCAE v 5.0
timeFrame: from the first treatment fraction up to 3 months
measure: Acute toxicity according to RTOG criteria
timeFrame: from the first treatment fraction up to 3 months
Secondary outcomes:
measure: Late toxicity according to CTCAE v 5.0
timeFrame: within 5 years after start of radiotherapy
measure: Late toxicity according to RTOG criteria
timeFrame: within 5 years after start of radiotherapy
measure: Quality of life assessment
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: Prostate specific quality of life assessment
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: EPIC-26 quality of life
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: IPSS quality of life
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: Freedom from biochemical failure
timeFrame: from start of radiotherapy until PSA relapse, assessed up to 5 years
measure: Disease-free survival
timeFrame: from start of radiotherapy until 5 years after treatment
measure: Overall survival
timeFrame: from start of radiotherapy until 5 years after treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Study officials:
affiliation: Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
name: Mark De Ridder, MD
role: PRINCIPAL_INVESTIGATOR
References: