NCT05715502

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
32mo left

Started May 2022

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2022Dec 2028

Study Start

First participant enrolled

May 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

April 30, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

December 13, 2022

Last Update Submit

April 28, 2025

Conditions

Prostate Cancer

Keywords

recurrenceprostate cancerbrachytherapyfocal treatmentsalvage treatmentradiotherapy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Assessment of the adverse events in the percentage of grades with the CTCAE v4.0

    24 months after treatment

Study Arms (1)

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

Interventions

brachytherapyRADIATION

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Poland Cancer Centre / Brachytherapy Department

Poznan, Greater Poland Voivodeship, 61-866, Poland

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33545689BACKGROUND

  • 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.

    PMID: 27568654BACKGROUND

  • 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.

    PMID: 17694553BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 30312717BACKGROUND

  • 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.

    PMID: 19245439BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsRecurrence

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Wojciech Burchardt, PhD, MD

    Greater Poland Cancer Centre / Brachytherapy Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Burchardt, PhD, MD

CONTACT

+48505149659wojciech.burchardt@wco.pl

Ewa Tańska, PhD, MSc.

CONTACT

+618850767ewa.tanska@wco.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

February 8, 2023

Study Start

May 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

April 30, 2025

Record last verified: 2025-01

Locations

PL(1)