Whole-gland prostate dose boost versus SBRT alone for PSMA-staged localized and locally advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PRO-BOOST-LC is a prospective, randomized phase II/III multicenter trial comparing biologically intensified whole-gland prostate dose escalation (HDR or LDR brachytherapy boost or stereotactic boost) against contemporary SBRT monotherapy. All participants must have no pelvic nodal or distant metastatic disease by baseline PSMA PET/CT and will receive protocol-defined external beam and boost regimens with allowed ADT per risk group. The trial measures clinically meaningful oncologic outcomes such as biochemical control, time to progression, and treatment-related toxicity. Randomization and modern PSMA staging are used to directly compare modern SBRT strategies with established brachytherapy and stereotactic boost approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male patients aged ≥18 years.
* Histologically confirmed adenocarcinoma of the prostate.
* Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.
* Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.
* NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.
* Candidate for definitive radiotherapy with curative intent.
* ECOG performance status 0-2.
* Baseline PSA available prior to randomization.
* Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.
* Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.
* Ability to understand and willingness to sign written informed consent.

Exclusion Criteria:

* Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.
* Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.
* Prior pelvic radiotherapy for any malignancy.
* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.
* History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).
* Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.
* Severe uncontrolled comorbidities that would preclude protocol treatment.
* Inability to comply with study procedures or follow-up schedule.

Where it's running

• Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
  Zamość, Lublin Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Mateusz Bilski, MD PhD — Affidea Nu-Med, Center of Oncological Diagnostics and Therapy, Zamość, Poland
• Study coordinator: Mateusz Edward Bilski, MD, PhD
• Email: bilskimat@gmail.com
• Phone: 048 84 535 99 10

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.