Focal Salvage Brachytherapy Study (FocaSaBra) (FocaSaBra)

Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: brachytherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wojciech Burchardt, Phd, MD; Phone Number: +48505149659; Email: wojciech.burchardt@wco.pl
• Study Contact Backup: Name: Ewa Tańska, PhD, MSc.; Phone Number: +618850767; Email: ewa.tanska@wco.pl

Study Locations

• Poland
  • Greater Poland
    • Poznań, Greater Poland, Poland, 61-866
      • Recruiting
      • Greater Poland Cancer Centre / Brachytherapy Department
      • Contact: Wojciech Burchardt, Phd, MD; Phone Number: +48505149659; Email: wojciech.burchardt@wco.pl
      • Contact: Ewa Tańska, PhD, MSc.; Phone Number: +618850767; Email: ewa.tanska@wco.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; 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; 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.

What is the study measuring?

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	Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale - IPSS within 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)	Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5): scale 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)	Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols, scale: 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	Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale: 0-5 grades	24 months after treatment

Collaborators and Investigators

• Sponsor: The Greater Poland Cancer Centre
• Investigators: Principal Investigator: Wojciech Burchardt, PhD, MD, Greater Poland Cancer Centre / Brachytherapy Department

Publications and helpful links

General Publications

• Mottet 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.
• Nguyen 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.
• Schaeffer 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.
• Crook, 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
• Crook 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.
• Aaronson DS, Yamasaki I, Gottschalk A, Speight J, Hsu IC, Pickett B, Roach M 3rd, Shinohara K. Salvage permanent perineal radioactive-seed implantation for treating recurrence of localized prostate adenocarcinoma after external beam radiotherapy. BJU Int. 2009 Sep;104(5):600-4. doi: 10.1111/j.1464-410X.2009.08445.x. Epub 2009 Feb 23.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: prostate cancer; radiotherapy; recurrence; brachytherapy; focal treatment; salvage treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FocaSaBra

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No