NCT04045717Active, not recruitingPhase 2
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
Source: ClinicalTrials.gov · Last updated 1 Dec 2023
Brief summary (registry, in English)
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, making use of hypofractionated stereotactic body radiotherapy with focal boosting. We are looking for the optimal overall treatment time for this treatment strategy in the Hypo-FLAME 2.0 trial. In this study the total treatment time will be halved (15 days) in comparison with the total treatment time in the former hypo-FLAME trial (29 days) (NCT02853110).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 19 Jul 2019
- Start date
- 10 Apr 2020
- Primary completion date
- 1 Jun 2022
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Prostate cancer
- NCT number
- NCT04045717
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 10 Apr 2020 to the primary completion date, 1 Jun 2022
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy or transurethral prostate resection
Other illness
- Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to gadolinium, severe renal dysfunction or severe claustrophobia)
Other
- Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance (non MR-linac)
- World Health Organization (WHO) performance score \> 2
- International prostate symptoms score (IPSS score) ≥ 15
- PSA \> 30 ng/mL
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| The Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.