Radiotherapy for recurrent prostate cancer using PSMA-PET guidance

PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer

This study is testing a new type of radiation therapy for men with recurring prostate cancer to see if it works better than the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 538 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: University Medical Center Groningen (Academic / other)
• Drugs / interventions: radiation
• Locations: 13 sites (Arnhem, Gelderland and 12 other locations)
• Trial ID: NCT04642027 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hypofractionated salvage external beam radiation therapy (sEBRT) in men who have experienced biochemical recurrence of prostate cancer after radical prostatectomy. The study aims to improve oncologic outcomes by increasing the biological effective radiation dose through a specific treatment schedule. Participants will be randomly assigned to receive either conventional sEBRT or the hypofractionated approach, with eligibility criteria focusing on specific PSA levels and absence of metastases. The trial is designed as a multicenter phase III study to gather comprehensive data on treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 to 80 who have undergone radical prostatectomy for prostate adenocarcinoma and have biochemical recurrence with a PSA level below 1.0 ng/ml.

Not a fit: Patients with prior pelvic irradiation, active invasive cancers, or evidence of lymph node or distant metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved long-term disease control for men with recurrent prostate cancer.

How similar studies have performed: Other studies have shown promise with hypofractionated radiation approaches, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Patients with prostate adenocarcinoma treated with radical prostatectomy;
* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;
* No lymph node or distant metastases. A recent PSMA-PET scan (\< 60 days) without evidence of lymph node or distant metastases;
* PSA progression after prostatectomy defined as two consecutive rises with the final PSA \> 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;
* PSA at inclusion \< 1.0 ng/mL;
* WHO performance status 0-2 at inclusion;
* Age at inclusion between 18 and 80 years;
* Written (signed and dated) informed consent prior to registration.

Exclusion Criteria:

* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;
* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;
* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;
* Double-sided metallic hip prosthesis;
* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

Where this trial is running

Arnhem, Gelderland and 12 other locations

• Radiotherapiegroep — Arnhem, Gelderland, Netherlands (Recruiting)
• Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (Recruiting)
• Maastro Clinic — Maastricht, Limburg, Netherlands (Recruiting)
• Catharina-Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
• Verbeeten Institute — Tilburg, North Brabant, Netherlands (Recruiting)
• Amsterdam UMC (Location VUmc) — Amsterdam, North Holland, Netherlands (Not_yet_recruiting)
• Radiotherapiegroep — Deventer, Overijssel, Netherlands (Recruiting)
• Radiotherapy Institute Friesland — Leeuwarden, Provincie Friesland, Netherlands (Recruiting)
• Leiden University Medical Center — Leiden, South Holland, Netherlands (Not_yet_recruiting)
• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
• Haga Hospital — The Hague, South Holland, Netherlands (Not_yet_recruiting)
• Zuidwest Radiotherapeutisch Instituut (ZRTI) — Flushing, Netherlands (Recruiting)
• Umcg — Groningen, Netherlands (Recruiting)

Study contacts

• Principal investigator: S. Aluwini, Dr. — University Medical Center Groningen
• Study coordinator: F. Staal, MD

Conditions Prostate Cancer; Cancer Recurrence; PSMA-PET/CT; Salvage; Hypofractionation; Radiotherapy; Prostatectomy