Focal Salvage Brachytherapy Study (FocaSaBra)

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.

Sex

Male

Minimum age

18 Years

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

• BACKGROUNDSchaeffer E, Srinivas S, Antonarakis ES, Armstrong AJ, Bekelman JE, Cheng H, D'Amico AV, Davis BJ, Desai N, Dorff T, Eastham JA, Farrington TA, Gao X, Horwitz EM, Ippolito JE, Kuettel MR, Lang JM, McKay R, McKenney J, Netto G, Penson DF, Pow-Sang JM, Reiter R, Richey S, Roach Iii M, Rosenfeld S, Shabsigh A, Spratt DE, Teply BA, Tward J, Shead DA, Freedman-Cass DA. NCCN Guidelines Insights: Prostate Cancer, Version 1.2021. J Natl Compr Canc Netw. 2021 Feb 2;19(2):134-143. doi: 10.6004/jnccn.2021.0008. PMID 33545689
• BACKGROUNDMottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25. PMID 27568654
• BACKGROUNDNguyen PL, D'Amico AV, Lee AK, Suh WW. Patient selection, cancer control, and complications after salvage local therapy for postradiation prostate-specific antigen failure: a systematic review of the literature. Cancer. 2007 Oct 1;110(7):1417-28. doi: 10.1002/cncr.22941. PMID 17694553
• BACKGROUNDCrook, J. M., Rodgers, J., Pisansky, T. M., Trabulsi, E., Amin, M., Bice, W., Morton, G., Pervez, N., Vigneault, E., Catton, C. N., Michalski, J. M., Roach, M., Beyer, D. C., Rossi, P. J., Horwitz, E. M., Donavanik, V., Sandler, H. M., Siva, S., Bressel, M., … Ball, D. (2020). Salvage Low Dose Rate Prostate Brachytherapy: Clinical Outcomes of a Phase II Trial for Local Recurrence after External Beam Radiotherapy (NRG/RTOG -0526). International Journal of Radiation Oncology, Biology, Physics, 108(3), S3. https://doi.org/10.1016/J.IJROBP.2020.07.2071
• BACKGROUNDCrook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.