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

Phase 2

Completed

Conditions: prostate cancer
prostate carcinoma
10038597
10025506

Registration Number: NL-OMON44816

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 85

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are acute gastrointestinal (GI) and<br /><br>genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse<br /><br>Events (CTCAE) version 4.0. </p><br>

Secondary Outcome Measures

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