Focal Salvage Brachytherapy Study (FocaSaBra)

The Greater Poland Cancer Centre

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05715502

FocaSaBra

Details and patient eligibility

About

The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.

Full description

Prostate cancer is the second most common cancer among men in Poland. Currently, a large number of diagnosed patients undergo radical radiotherapy. Despite the high effectiveness of treatment, some patients experience failures in the form of regional and / or distant metastases, most often in the form of isolated local recurrence. In patients with suspected local recurrence, we can decide on emergency treatment after PET, pelvic MRI with an assessment of the prostate gland, and after excluding metastases. The oncological(NCCN ) and urological (EUA) recommendations allow salvage surgical treatment, observation, palliative pharmacological castration, or treatment using salvage brachytherapy.

Salvage surgical treatment is associated with a 30-65% chance of cure in the top cancer centers in the world, and the risk of significant toxicity ranges from 17 to 48%.

Treatment with brachytherapy, due to the intra-tissue nature and the short therapeutic range of radiation, can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs, e.g., rectum and/or bladder. Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65% of patients, according to the prospective study RTOG 0526. However, emergency treatment in this study was associated with a 14% risk of significant post-treatment toxicity requiring medical intervention. There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland (focal brachytherapy), but they are only retrospective. They show significant treatment efficacy and lower toxicity.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)
• Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
• Exclusion of distant metastases using CT, MR, or PET imaging
• PSA doubling time over six months
• PSA value <10 ng / ml
• No anti-androgen treatment in the year prior
• Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points
• General condition according to the WHO scale ≤ 2
• Signing informed consent to participate in the study

Exclusion criteria

• PSA value> 10ng / ml
• General condition according to the WHO scale> 2
• Dysuria on the IPSS scale> 20 points
• PSA doubling time <6 months
• Inability to discontinue anticoagulants.
• An active urinary tract infection.
• Contraindications to general anesthesia
• Active inflammatory bowel diseases.
• Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
• Estimated Survival <5 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Experimental

Experimental group

Description:

Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.

Treatment:

Radiation: brachytherapy