Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

NCT05746806 | Active Not Recruiting

• 1 other identifier: 2022-01026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.

Conditions

Recurrent Prostate Cancer

Keywords

Prostate; Salvage Radiation; Local recurrence; Stereotactic radiotherapy; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• Biochemical relapsefree survival

  The initial prostate specific antigen (PSA) at time of registration will be the starting point. Freedom from biochemical progression is counted from the day of registration to the day of either first recorded biochemical progression as defined below, clinical progression or death due to clinical progression. Biochemical relapsefree survival measured with PSA (prostate specific antigen) lab testing at 1, 3, 6, 12, 18 and 24 months after radiotherapy. The duration of biochemical relapsefree survival is measured and documented in months for each patient. A biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/mL with a confirmatory rise at least 2 weeks later. For those patients whose PSA does not drop below 0.20 ng/mL at time of first response assessment at 3 months are considered as non-responders to treatment and are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA above this level.

  2 years

Secondary Outcomes (6)

• Acute side effects of grade 3 or higher

  90 days

• Clinical progression-free survival

  2 years

• Metastasis-free survival

  2 years

• Late side effects

  After 90 days up to 2 years (after acute side effects, see outcome 2)

• Quality of life (EORTC Quality of life questionnaire C-30 version 3)

  2 years

Study Arms (1)

Single arm

EXPERIMENTAL

Patients with locally recurred prostate cancer will receive a ultrahypofractionated stereotactic radiotherapy to the radiologically identified lesion (Dose: 5 fractions with 7Gray every second work week day) combined with an androgen deprivation therapy (LHRH-agonist / -antagonist) for 6 months.

Radiation: Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy; Drug: Androgen deprivation therapy

Interventions

Androgen deprivation therapy DRUG

In combination to the radiotherapy a short term androgen deprivation drug for 6 months will be applied. The preferred drug concept used is: \- LHRH(Luteinizing hormone releasing hormone)-agonist with 3-month subcutaneous depot injection (e.g. Pamorelin® LA (Triptorelin) 11.25mg s.c.) in combination with nonsteroidal antiandrogen (e.g. Bicalutamide 50mg/day) as flare protection at least 5 days before and max. 15 days after first LHRH-injection Alternatively the following oral drug concept can be used, if the patient rejects injections: \- GnRH (gonadotropin-releasing hormone)-antagonist with tablet intake for 6 months (e.g. Orgovyx® Tablets 120mg; first day 360mg, after second day 120mg per day)

Single arm

Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy RADIATION

Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions

Single arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
• Age ≥ 18 years at time of registration
• WHO performance status 0-1
• Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN0. according to the Union for International Cancer Control (UICC) TNM 2009.
• Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended.
• Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
• Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
• Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

You may not qualify if:

• Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP
• Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
• Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy
• Bilateral hip prosthesis
• Severe or active co-morbidity likely to impact on the advisability of SRT
• Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Debiopharm International SA: collaborator
• Werner und Hedy Berger-Janser - Stiftung: collaborator

Study Sites (5)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC)

Bellinzona, 6500, Switzerland

Location

Inselgruppe AG, Inselspital

Bern, 3010, Switzerland

Location

Kantonsspital Winterthur, Klinik für Radio-Onkologie

Winterthur, 8401, Switzerland

Location

Universitätsspital Zürich, Klinik für Radio-Onkologie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Mathier E, Althaus A, Zwahlen D, Lustenberger J, Zamboglou C, De Bari B, Aebersold DM, Guckenberger M, Zilli T, Shelan M. HypoFocal SRT Trial: Ultra-hypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy; single-arm phase II study; clinical trial protocol. BMJ Open. 2024 Jan 30;14(1):e075846. doi: 10.1136/bmjopen-2023-075846.

  PMID: 38296279 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mohamed MS Shelan, PD

  Department of radiation oncology, Bern University Hospital, Inselspital, Berne, Switzerland

  STUDY DIRECTOR

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: February 16, 2023
• First Posted: February 28, 2023
• Study Start: March 29, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)