Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

NCT06201078 | Recruiting Phase 2

• 1 other identifier: nio-kb/430-72/23
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy. The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control with other secondary endpoints which include: Biochemical Response, Biochemical Failure-Free Survival, Metastases-Free Survival, Relapse-Free Survial, Local Control, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25). The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated/moderately hypofractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B). The study group is planned to include 55 patients.

Conditions

Local Recurrence of Malignant Tumor of Prostate; Radiotherapy

Keywords

local recurrence; prostate; radiotherapy; salvage

Outcome Measures

Primary Outcomes (1)

• Tolerance of salvage SBRT

  Assessment of early and late radiation toxicity: Grade ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria

  3 months post-SBRT, 2-years post-SBRT

Secondary Outcomes (9)

• Tolerance of salvage SBRT

  3 months post-SBRT, every 6 months post SBRT up to 3-years post-SBRT

• Biochemical Control

  3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT

• Biochemical Response

  3 months post-SBRT, 6 months post-SBRT, every 6 moths thereafter up to 5-years post-SBRT

• Biochemical Failure-Free Survival (BFS)

  3 months post-SBRT, 6 months post SBRT, every 6 months thereafter up to 5-years post-SBRT

• Metastases-Free Survival

  1-year post SBRT, then annually up to 5-years post-SBRT

Study Arms (1)

Salvage SBRT for locally recurrent prostate cancer after radiotherapy

EXPERIMENTAL

SBRT: 5 x 6.75 Gy (every other day) to the total dose of 33.75 Gy

Radiation: Stereotactic Body Radiotherapy

Interventions

Stereotactic Body Radiotherapy RADIATION

Salvage SBRT will be performed in three subgroups of patients with local recurrence: Group A - after conventionally fractionated/moderately hypofractionated definitive radiotherapy; Group B - after prostatectomy and postoperative radiotherapy; Group C - after ultrahypofractionated definitive SBRT Target volumes: GTV- tumour visible on MRI and PET-CT; CTV- 1-3 mm margin around GTV PTV- 3 mm around CTV\* \*- in cases in which very high accuracy and reproducibility of SBRT are ensured, and the margin overlaps the rectum and/or bladder, it is possible to reduce the margin from these organs to 1 mm. Dose constrains: The criteria for limiting the dose in nearby organs are not well-defined for repeated irradiation - the following doses should be aimed: * Maximum rectal dose ≤103% of the prescribed dose (optimal ≤100%) * Maximum bladder dose ≤105% of the prescribed dose (optimal ≤103%) Dose-volume constrains: Rectum: • D30% \<15Gy Bladder: • D30% \< 15 Gy

Salvage SBRT for locally recurrent prostate cancer after radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Local recurrence of prostate cancer after definitive radiotherapy
• biopsy proven or/and
• Consistent MRI and PET-PSMA results and PSA growth dynamics
• Time since primary radiotherapy - at least 2 years
• Good performance status (ZUBROD 0-1)
• If the results of the MRI and PET PSMA are inconsistent, and if there is no technical possibility of performing an MRI biopsy, the treatment is acceptable, but repeated imaging (PET or MRI) should be performed to assess the dynamics of the recurrence.

You may not qualify if:

• Polymetastatic dissemination in distant or regional lymph nodes (N1, M1) or oligometastatic dissemination, but not eligible for local forms of metastasis directed therapy (MDT)
• Tumour volume (GTV) \> 14 cc
• Poor tolerability of primary radiotherapy (≥G3 toxicity) or persistent late toxicity ≥G2 interfering with re-irradiation
• Severe dysuria before repeated SBRT (e.g., IPSS ≥19)
• Diseases of the distal part of the rectum or anal canal that may affect SBRT tolerance (e.g., anal fissure)
• Previous prostate brachytherapy
• Substantial risk for further urologic interventions (e.g., TURB/TURP)

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska Memorial Research Institute of Oncology

Gliwice, 44-100, Poland

RECRUITING

Related Publications (5)

• Valle LF, Lehrer EJ, Markovic D, Elashoff D, Levin-Epstein R, Karnes RJ, Reiter RE, Rettig M, Calais J, Nickols NG, Dess RT, Spratt DE, Steinberg ML, Nguyen PL, Davis BJ, Zaorsky NG, Kishan AU. A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). Eur Urol. 2021 Sep;80(3):280-292. doi: 10.1016/j.eururo.2020.11.010. Epub 2020 Dec 11.

  PMID: 33309278 BACKGROUND

• Miszczyk M, Kraszkiewicz M, Moll M, Kaminiow K, Sobel S, Dolla L, Wojcieszek P, Rajwa P, Yanagisawa T, Nowicka Z, Shariat SF, Goldner G, Miszczyk L, Majewski W. Long-Term Outcomes of Stereotactic Body Radiotherapy (SBRT) for Intraprostatic Relapse after Definitive Radiotherapy for Prostate Cancer: Patterns of Failure and Association between Volume of Irradiation and Late Toxicity. Cancers (Basel). 2023 Feb 13;15(4):1180. doi: 10.3390/cancers15041180.

  PMID: 36831523 BACKGROUND

• Jereczek-Fossa BA, Marvaso G, Zaffaroni M, Gugliandolo SG, Zerini D, Corso F, Gandini S, Alongi F, Bossi A, Cornford P, De Bari B, Fonteyne V, Hoskin P, Pieters BR, Tree AC, Arcangeli S, Fuller DB, Franzese C, Hannoun-Levi JM, Janoray G, Kerkmeijer L, Kwok Y, Livi L, Loi M, Miralbell R, Pasquier D, Pinkawa M, Scher N, Scorsetti M, Shelan M, Toledano A, van As N, Vavassori A, Zilli T, Pepa M, Ost P; on the behalf of the European Society for Radiotherapy, Oncology Advisory Committee on Radiation Oncology Practice (ESTRO ACROP). Salvage stereotactic body radiotherapy (SBRT) for intraprostatic relapse after prostate cancer radiotherapy: An ESTRO ACROP Delphi consensus. Cancer Treat Rev. 2021 Jul;98:102206. doi: 10.1016/j.ctrv.2021.102206. Epub 2021 Apr 20.

  PMID: 33965893 BACKGROUND

• Archer P, Marvaso G, Detti B, Colombo F, Francolini G, Vandendorpe B, Thananayagam MA, Baty M, De Crevoisier R, Alongi F, Nicosia L, Scher N, Toledano A, Di Muzio N, Fodor A, Zilli T, Franzese C, Scorsetti M, Shelan M, Triggiani L, Aymes E, Le Deley MC, Jereczek-Fossa BA, Pasquier D. Salvage Stereotactic Reirradiation for Local Recurrence in the Prostatic Bed After Prostatectomy: A Retrospective Multicenter Study. Eur Urol Oncol. 2023 Jun;6(3):303-310. doi: 10.1016/j.euo.2023.03.005. Epub 2023 Apr 1.

  PMID: 37012102 BACKGROUND

• Schroder C, Tang H, Windisch P, Zwahlen DR, Buchali A, Vu E, Bostel T, Sprave T, Zilli T, Murthy V, Forster R. Stereotactic Radiotherapy after Radical Prostatectomy in Patients with Prostate Cancer in the Adjuvant or Salvage Setting: A Systematic Review. Cancers (Basel). 2022 Jan 29;14(3):696. doi: 10.3390/cancers14030696.

  PMID: 35158961 BACKGROUND

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wojciech Majewski, MD, PhD

  Maria Sklodowska Curie Memorial Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Majewski, MD, PhD

CONTACT

+48322788001; wojciech.majewski@gliwice.nio.gov.pl

Aleksandra Napieralska, MD, PhD

CONTACT

+48322788001; aleksandra.napieralska@gliwice.nio.gov.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 11, 2024
• Study Start: July 31, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

PL (1)