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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-guided prostate stereotactic body radiotherapy | Experimental | Patients will receive MR-guided RT in 5 fractions over 7 days (daily excluding weekend, i.e. start on Wednesday or Thursday, until Tuesday or Wednesday respectively the week after). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided RT | Radiation | The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy < 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity according to CTCAE v 5.0 | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0 | from the first treatment fraction up to 3 months |
| Acute toxicity according to RTOG criteria | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria | from the first treatment fraction up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity according to CTCAE v 5.0 | Clinician reported late toxicity, assessed using CTCAE v 5.0 | within 5 years after start of radiotherapy |
| Late toxicity according to RTOG criteria | Clinician reported late toxicity, assessed using RTOG criteria |
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Inclusion Criteria:
Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark De Ridder, MD | Contact | 00324776041 | mark.deridder@uzbrussel.be | |
| Jacques Bezuidenhout, MD | Contact | jacques.bezuidenhout@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Mark De Ridder, MD | Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel | Recruiting | Brussels | Belgium |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| within 5 years after start of radiotherapy |
| Quality of life assessment | Quality of life according to EORTC Quality of life Questionnaire C30 | from the start of radiotherapy until 5 years after treatment |
| Prostate specific quality of life assessment | Quality of life according to EORTC Quality of life Questionnaire PR25 | from the start of radiotherapy until 5 years after treatment |
| EPIC-26 quality of life | Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26) | from the start of radiotherapy until 5 years after treatment |
| IPSS quality of life | Quality of life according to International Prostate Symptom Score (IPSS) | from the start of radiotherapy until 5 years after treatment |
| Freedom from biochemical failure | the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL) | from start of radiotherapy until PSA relapse, assessed up to 5 years |
| Disease-free survival | from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause | from start of radiotherapy until 5 years after treatment |
| Overall survival | from start of radiotherapy until death from any cause | from start of radiotherapy until 5 years after treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |