Prostate Cancer
Conditions
Brief summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Detailed 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.
Interventions
RADIATIONHigh dose rate brachytherapy
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Sponsors
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to castration-resistant prostate cancer | 10 years | The time from intervention until the prostate cancer becomes castration resistant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectile dysfunction | 5 years | Erectile dysfunction as reported by patients in CTCAE PRO |
| Urinary symptoms | 5 years | Urinary symptoms as reported by patients in CTCAE PRO |
| Bowel symptoms | 5 years | Bowel symptoms as reported by patients in CTCAE PRO |
Countries
Denmark
Contacts
Primary ContactSimon Buus, MD
Outcome results
None listed