NCT04045717

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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).

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 weeks (i.e. 35-40 fractions, 5x/week). Recent studies have identified a proportionally longer overall treatment time as a potential adverse factor for treatment outcome in prostate cancer patients who were treated by conventional radiotherapy schedules. Furthermore shortening of the overall treatment time promotes patient convenience. An extreme shortening of the overall treatment time is possible by using hypofractionated treatment schedules with simultaneous integrated intraprostatic tumor boosting to overcome local recurrences. Objective: In this study we will investigate 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). Besides a potential biological advantage, the reduced overall treatment time offers benefits with respect to patient convenience. Study population: One hundred twenty four patients with histologically proven intermediate- or high-risk prostate cancer will be included in this multicenter phase II study. Patients referred for external beam radiotherapy who fulfil the inclusion criteria and without any of the exclusion criteria will be included in the present trial after written informed consent. Intervention: Patients will be treated with a stereotactic body radiation therapy technique up to 35 Gray in 5 fractions of 7 Gray to the whole prostate gland. Additionally a simultaneously integrated focal boost to the macroscopic tumor nodule(s) visible on MRI up to 50 Gray (10 Gray/fraction) will be delivered. Treatment fractions will be delivered twice weekly, resulting in an overall treatment time of 2,5 weeks. Main study endpoints: The primary endpoint of this study is acute gastrointestinal and genitourinary toxicity, scored using the Common Terminology Criteria Adverse Events version 5.0. Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and biochemical disease free survival defined by the Phoenix consensus definition.

Conditions

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Neoplasm

Interventions

Type	Name	Description
RADIATION	Hypo-FLAME 2.0 study	SBRT technique with 35 Gy in 5 fractions to the whole prostate gland and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy (overall treatment time (OTT) = 15 days).

Timeline

• Start date: 2020-04-10
• Primary completion: 2022-06-01
• Completion: 2032-02-16
• First posted: 2019-08-05
• Last updated: 2023-12-01

Locations

3 sites across 2 countries: Belgium, Netherlands