Comparing two types of radiotherapy for prostate cancer treatment
Standard Moderately Hypofractionated Radiotherapy vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer, Hypo-FLAME 3.0
This study is testing if a new type of radiotherapy that uses higher doses in fewer sessions can help men with localized prostate cancer live longer without the disease coming back compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05705921 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of standard moderately hypofractionated radiotherapy with an ultra-hypofractionated focal lesion ablative microboost approach in treating prostate cancer. The objective is to demonstrate that the new method, which delivers a higher dose in fewer sessions, leads to better five-year biochemical disease-free survival rates. Eligible participants include men with localized prostate adenocarcinoma who meet specific risk criteria and have no evidence of metastases. The study will assess outcomes based on established definitions and criteria for prostate cancer treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed prostate adenocarcinoma and specific intermediate or high-risk characteristics.
Not a fit: Patients with prior pelvic radiotherapy or those who have undergone recent transurethral prostate resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with intermediate and high-risk prostate cancer, potentially improving their long-term survival rates.
How similar studies have performed: Previous studies have shown promising results with similar hypofractionated approaches in prostate cancer treatment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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 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.
Where this trial is running
Amsterdam
- Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Floris Pos, MD PhD — The Netherlands Cancer Institute
- Study coordinator: Floris Pos, MD PhD
- Email: f.pos@nki.nl
- Phone: +31 20 512 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.