Standard moderately hypofractionated radiotherapy vs. ultra-hypofractionated focal lesion ablative microboost in prostate cancer, Hypo-FLAME 3.0

Phase 3

Recruiting

Conditions: prostate cancer
10038597

Registration Number: NL-OMON56327

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 352

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
criteria
- 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
• 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biochemical disease free survival (bDFS) will be defined at time from<br /><br>randomization until biochemical failure (defined by the Phoenix consensus<br /><br>definition PSA > nadir + 2 ng/mL) [12]. Biochemical outcome data will be<br /><br>obtained by performing a PSA test at day 90, month 6 and every 6 months up to 3<br /><br>years and after that every year up to 5 years. Death without biochemical<br /><br>recurrence is not considered an event</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Acute and late GU and GI toxicity according to the CTCAE v5.0.<br /><br><br /><br>Patient-Reported Outcome Measures (PROMs) will be assessed up to 3 years using<br /><br>the International Prostate Symptom Score (IPSS) questionnaire, the European<br /><br>Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire<br /><br>and the EPIC-26 questionnaire.<br /><br><br /><br>Disease-free survival<br /><br>Distant metastases-free survival Prostate cancer-specific survival Overall<br /><br>survival </p><br>