Salvage HDR for Locally Recurrent Prostate Cancer (PROSALBRA)

Aarhus University Hospital

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: High dose rate brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04231006

1-10-72-218-19

Details and patient eligibility

About

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Full description

The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
• ≥ 2 years since the end of primary radiotherapy
• PSA recurrence Phoenix criteria (nadir + 2)
• No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
• MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
• GTV identifiable on mpMRI
• No current endocrine therapy
• Plasma testosterone ≥1.75 nm/l
• PSA doubling time ≥ 6 months and ≤ 24 months
• Performance status 0-1
• DAN PSS score ≤ 20
• Maximal urinary flow ≥ 10 ml/s
• Life expectancy > 5 years
• PSA ≤ 10 ug/L at recurrence

Exclusion criteria

• Pubic arc interference or major calcifications within the prostate gland.
• Contraindication for spinal or general anaesthesia.
• Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
• Inflammatory bowel disease
• Contraindications to 3T MRI
• eGFR < 30 ml/min
• ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4

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

Single arm

Experimental group

Description:

Single arm

Treatment:

Radiation: High dose rate brachytherapy