Focal salvage radiotherapy for recurrent prostate cancer after surgery

A Single Arm Phase II Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

This study is testing a new way to treat men with recurring prostate cancer after surgery by using focused radiation therapy along with a short course of hormone therapy to see if it helps improve their outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Male
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 5 sites (Basel and 4 other locations)
• Trial ID: NCT05746806 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness and safety of combining short-term androgen deprivation therapy with focal ultrahypofractionated salvage radiotherapy for patients experiencing local recurrence of prostate cancer after radical prostatectomy. The treatment involves delivering radiation in five fractions to the identified site of recurrence, guided by advanced imaging techniques such as multiparametric MRI and PSMA PET/CT. The study aims to provide a precise and targeted approach to treating isolated prostate bed recurrences.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with non-metastatic prostate cancer who have experienced a local recurrence after radical prostatectomy.

Not a fit: Patients with metastatic disease or those who have previously received hormonal therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and less invasive option for patients with recurrent prostate cancer, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise with similar approaches in treating localized prostate cancer recurrences, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
2. Age ≥ 18 years at time of registration
3. WHO performance status 0-1
4. 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.
5. 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.
6. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
7. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
8. Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
9. 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

Exclusion Criteria:

1. Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP
2. Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
3. 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
4. Bilateral hip prosthesis
5. Severe or active co-morbidity likely to impact on the advisability of SRT
6. 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)

Where this trial is running

Basel and 4 other locations

• Universitätsspital Basel — Basel, Switzerland (Recruiting)
• Istituto Oncologico della Svizzera Italiana-Ente Ospedaliero Cantonale (IOSI-EOC) — Bellinzona, Switzerland (Recruiting)
• Inselgruppe AG, Inselspital — Bern, Switzerland (Recruiting)
• Kantonsspital Winterthur, Klinik für Radio-Onkologie — Winterthur, Switzerland (Recruiting)
• Universitätsspital Zürich, Klinik für Radio-Onkologie — Zürich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Mohamed MS Shelan, Assistant Professor

Conditions Recurrent Prostate Cancer; Prostate; Salvage Radiation; Local recurrence; Stereotactic radiotherapy; Hypofractionation