Focal Salvage Brachytherapy Study (FocaSaBra)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin. | Radiation: brachytherapy<br>* Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale (IPSS (0-35 points) |  | change from baseline to 24 months of follow-up | 
| Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points) |  | change from baseline to 24 months of follow-up | 
| Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points) |  | change from baseline to 24 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale (0-5 grades) |  | 24 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrence, prostate cancer, brachytherapy, focal treatment, salvage treatment, radiotherapy