Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial (FOKAL-BT)

University of Erlangen-Nürnberg Medical School

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: HDR-Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02391051

FOKAL-BT

Details and patient eligibility

About

This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Full description

Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Histologically confirmed prostate cancer
• Gleason Score of index lesion ≤ 6 (3+3)
• Tumor stage: cT1-2a cN0 cM0
• Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
• PSA ≤ 10/ng/ml
• Prostate volume < 60 m^3
• No distant metastasis
• Life expectancy > 10 years
• Informed consent

Exclusion criteria

• Tumor stage ≥ T2b
• Known metastasis: N+ and/or M1
• General anesthesia or peridural anesthesia is not possible
• Coagulation disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Focal Brachytherapy

Experimental group

Description:

HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy

Treatment:

Radiation: HDR-Brachytherapy