Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME)

Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME) - Hypo-FLAME

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44816

Enrollment

Registered

2016-03-16

Start date

2016-04-13

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate carcinoma

Interventions

Patients will be treated by external beam radiotherapy with a SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Men >= 18 years with histologically confirmed prostate adenocarcinoma; - Intermediate-risk prostate cancer or high-risk prostate cancer, defined as at least one of the following risk criteria: * Clinical T-stage T2b, T2c or T3a (defined on MRI) or T3b with less than 5 mm invasion in the seminal vesicle. * Gleason sum score >= 7. * Prostate specific antigen (PSA) >= 10 ng/mL. - Prostate tumor nodule visible on MRI; - Ability to give written informed consent and willingness to return for follow-up.

Exclusion criteria

Exclusion criteria: - Prior pelvic radiotherapy, transurethral prostate resection or prostatectomy; - Unsafe to have gold fiducial marker implantation; - Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to Gadolinium, severe renal dysfunction or severe claustrophobia); - Evidence of lymph node involvement or distant metastatic disease; - Clinical T-stage > T3b with >= 5 mm invasion in theseminal vesicle; - World Health Organization (WHO) performance score > 2; - International prostate symptoms score (IPSS) >= 15; - PSA >30 ng/mL.

Design outcomes

Primary

Measure	Time frame
The primary endpoints of this study are acute gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	—

Secondary

Measure	Time frame
Secondary endpoints are late GI and GU toxicity, QoL, and bDFS. Simultaneously, two side-studies will be performed, i.e. to prepare for MRI-guided radiotherapy (except for Radboudumc and UZ Leuven) and blood sampling for translational research (radiogenomics) and Biobank purposes (except for Radboudumc).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)