MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Prostate Cancer Clinical Trial

— Proseven  

Official title:

Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896801
• Other study ID #: PRO7
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: July 2029

Study information

• Verified date: June 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Mark De Ridder, MD
• Phone: 00324776041
• Email: mark.deridder[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2029
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• MR-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

Locations

Country	Name	City	State
Belgium	Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Late toxicity according to RTOG criteria	Clinician reported late toxicity, assessed using RTOG criteria	within 5 years after start of radiotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	IPSS quality of life	Quality of life according to International Prostate Symptom Score (IPSS)	from the start of radiotherapy until 5 years after treatment
Secondary	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
Secondary	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
Secondary	Overall survival	from start of radiotherapy until death from any cause	from start of radiotherapy until 5 years after treatment