Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Netherlands Cancer Institute
With
Radboud University Medical Center
Universitaire Ziekenhuizen KU Leuven
Objective of the study:
To demonstrate superiority of whole gland SBRT with a simultaneous integrated focal boost 35/50 Gy in 5 fractions (Hypo-FLAME) regarding 5-year bDFS compared to the current standard moderately hypofractionated schedule of 62 Gy in 20 fractions of 3.1 Gy. bDFS will be assessed, using the Phoenix consensus definition.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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 criteria (note; both the clinical T-stage and imaging T stage are noted in the CRF):
* clinical stage cT2c-T3a (UICC TNM 8th edition)
* 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
International prostate symptoms score (IPSS score) \< 15
PSA ≤ 30 ng/mL
Prostate volume ≤ 90 cc on MRI
Ability to give written informed consent and willingness to return for follow-up
You may not be if
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.
Clareo Health | Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer
