Prostate Cancer
Conditions
Keywords
MR-guided radiotherapy, Stereotactic body radiotherapy
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.
Interventions
RADIATIONMR-guided RT
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
Sponsors
Universitair Ziekenhuis Brussel
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity according to CTCAE v 5.0 | from the first treatment fraction up to 3 months | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0 |
| Acute toxicity according to RTOG criteria | from the first treatment fraction up to 3 months | Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | from the start of radiotherapy until 5 years after treatment | Quality of life according to EORTC Quality of life Questionnaire C30 |
| Prostate specific quality of life assessment | from the start of radiotherapy until 5 years after treatment | Quality of life according to EORTC Quality of life Questionnaire PR25 |
| EPIC-26 quality of life | from the start of radiotherapy until 5 years after treatment | Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26) |
| Late toxicity according to CTCAE v 5.0 | within 5 years after start of radiotherapy | Clinician reported late toxicity, assessed using CTCAE v 5.0 |
| Freedom from biochemical failure | from start of radiotherapy until PSA relapse, assessed up to 5 years | the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL) |
| Disease-free survival | from start of radiotherapy until 5 years after treatment | from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause |
| Overall survival | from start of radiotherapy until 5 years after treatment | from start of radiotherapy until death from any cause |
| IPSS quality of life | from the start of radiotherapy until 5 years after treatment | Quality of life according to International Prostate Symptom Score (IPSS) |
| Late toxicity according to RTOG criteria | within 5 years after start of radiotherapy | Clinician reported late toxicity, assessed using RTOG criteria |
Countries
Belgium
Contacts
Primary ContactMark De Ridder, MD
Backup ContactJacques Bezuidenhout, MD
Outcome results
None listed