Status:
ACTIVE_NOT_RECRUITING
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
The Netherlands Cancer Institute
Radboud University Medical Center
Conditions:
Prostate Adenocarcinoma
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The hypo-FLAME 2.0 study is a multicenter phase II study (n=124) investigating the feasibility and safety of a reduction in the overall treatment time of radiotherapy for prostate cancer patients, mak...
Detailed Description
Rationale: External beam radiotherapy is one of the standard treatment options for patients with prostate cancer. The overall treatment time of a standard fractionated schedule varies between 7 and 8 ...
Eligibility Criteria
Inclusion
- Men ≥ 18 years with histologically confirmed prostate adenocarcinoma
- Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
- Clinical stage: T2b, T2c, T3a or T3b with less than 5 mm invasion in the seminal vesicles (defined on MRI) N0 M0
- Gleason sum score ≥ 7
- PSA ≥ 10 ng/mL.
- Prostate tumor nodule visible on mpMRI
- Ability to give written informed consent and willingness to return for follow-up
Exclusion
- Prior pelvic radiotherapy or transurethral prostate resection
- Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance (non MR-linac)
- Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to gadolinium, severe renal dysfunction or severe claustrophobia)
- World Health Organization (WHO) performance score \> 2
- International prostate symptoms score (IPSS score) ≥ 15
- PSA \> 30 ng/mL
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 16 2032
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04045717
Start Date
April 10 2020
End Date
February 16 2032
Last Update
December 1 2023
Active Locations (3)
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1
University Hospitals Leuven
Leuven, Belgium, 3000
2
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
3
Radboudumc
Nijmegen, Netherlands, 6525 GA