Salvage HDR for Locally Recurrent Prostate Cancer

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

Detailed Description
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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.

Official Title
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Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: High dose rate brachytherapy


Participation Criteria
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Eligibility Criteria
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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

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: Single arm<br>Single arm | Radiation: High dose rate brachytherapy<br>* High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to castration-resistant prostate cancer | The time from intervention until the prostate cancer becomes castration resistant | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile dysfunction | Erectile dysfunction as reported by patients in CTCAE PRO | 5 years | 
| Urinary symptoms | Urinary symptoms as reported by patients in CTCAE PRO | 5 years | 
| Bowel symptoms | Bowel symptoms as reported by patients in CTCAE PRO | 5 years |