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Local HDR brachytherapy in case of localized prostate cancer

Local HDR brachytherapy in case of localized prostate cancer - ProFocAL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010911
Enrollment
25
Registered
2016-08-29
Start date
2016-11-09
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C61

Interventions

Group 1: If prostate carcinoma is shown, we recommend a minimally invasive intervention in the radiology department. Among nuclear spin magnetic resonance imaging conditions targeted brachytherapy of

Sponsors

Universitätsklinik für Radiologie und Nuklearmedizin
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 80 years, with a localized tumor of the prostate under low-risk or intermediate risk early to D'Amico, the standard procedures, such as percutaneous radiotherapy, radical prostatectomy or active surveillance refuse. In preoperatively performed multiparametric MRI (mpMRT) at least one suspicious lesion with a PI-RADS score must be described by 4/5. • Age 18 aged 80 or a life expectancy of at least 10 years • MR biopsy or prostate fusionsbioptisch secured • In accordance distinctly visible index lesions with PI-RADS score 4/5 • consent of focal treatment by using brachytherapy • refusal of also introduced standard treatments

Exclusion criteria

Exclusion criteria: several suspect lesion in mpMRT with a PI-RADS score of 4/5. Furthermore, symptoms that preoperatively additional treatments of the prostate makes necessary (z. B. TURP) equipment and other obstacles which do not allow to carry out the therapy. • Missing capacity to consent • evidence of lymph node or metastasis in the CT or MRI • no suspect MR lesion (PIRADS 4/5) • several suspect MR lesions (PIRADS 4/5) • ongoing antihormonal therapy

Design outcomes

Primary

MeasureTime frame
Objective of the study is to establish a new method of treatment for prostate cancer, showing minimal side effects for the patient. Parameters will be analyzed with a Safety (SAE management / side effect and quality of life questionnaires) which will be collected during study.

Secondary

MeasureTime frame
Evidence based of improvment in quality of life compared with standard therapy methods by patient satisfaction.

Countries

Germany

Contacts

Public ContactSybille Voigt

Universitätsklinik für Radiologie und Nuklearmedizin

sybille.voigt@med.ovgu.de+49-391-67-13071

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026