NL-OMON56327
Recruiting
Phase 3
Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0 - Hypo-FLAME 3.0
Antoni van Leeuwenhoek Ziekenhuis0 sites352 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- prostate cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 352
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men \>\= 18 years with histologically confirmed prostate adenocarcinoma
- •No evidence of lymph node or distant metastases N0M0\.
- •MRI visible tumor on mpMRI (PI\-RADS v2 \>\= 4\).
- •Intermediate\- or high\-risk PCa, defined as at least one of the following risk
- •\- clinical stage cT2c\-T3a (UICC TNM 8th edition) \[13]
- •\- Imaging stage T2c, T3a or T3b with less than 5 mm invasion in the seminal
- •vesicles (as defined on mp MRI)
- •\- \>\= Gleason score 4\+3, (ISUP Grade groups 3,4 or 5\)
- •\- PSA \>\= 20 ng/mL
- •World Health Organization (WHO) performance score \<\= 2
Exclusion Criteria
- •Prior pelvic radiotherapy
- •TURP (transurethral prostate resection) within 6 months from start treatment
- •On\-line image guidance based on either fiducial markers or high\-quality CBCT
- •or MRI according to local guidelines not feasible. For example: Unsafe to have
- •gold fiducial marker implantation, if gold fiducial markers are used for image
- •guidance. Distorted images on MR because of hip protheses prohibit accurate MR
- •image guidance, if MR is used for image guidance.
- •Contraindications to MRI according to local hospital guidelines
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Intensity-modulated, hypofractionated radiotherapy with scanning beam protons for locally advanced carcinoma of the prostate and localized carcinoma of the prostate with risk factors - a phase II studyC61Malignant neoplasm of prostateDRKS00011912Westdeutsches Protonentherapiezentrum Essen (WPE)133
Completed
Phase 1
Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trialprostate cancerJPRN-UMIN000014328Osaka University Graduate School of Medicine75
Recruiting
Phase 2
Two-fraction Ultra-hypofractionated Radiotherapy with Focal Boost for low- and intermediate risk, localized prostate cancer (TURBO):phase II, randomized controlled clinical trialprostate adenocarcinomaprostate cancer100276561001818810036958NL-OMON56580niversitair Medisch Centrum Utrecht160
Recruiting
Not Applicable
HYpofractionated, Dose-redistributed RAdiotherapy with protons and photons to combat radiation-induced immunosuppression in head and neck squamous cell carcinomaHead and neck squamous cell carcinoma10027655NL-OMON53777Erasmus MC, Universitair Medisch Centrum Rotterdam154
Active, not recruiting
Not Applicable
Sequential hypofractionated radiotherapy followed by anti-PD-L1 atezolizumab for recurrent or refractory small cell lung cancerKCT0005443ational Cancer Center35