Whole-gland prostate dose boost versus SBRT alone for PSMA-staged localized and locally advanced prostate cancer
PRO-BOOST-LC: A Prospective, Multi-arm Phase II/III Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET/CT
PHASE2; PHASE3 · Affidea Nu-med Center of Oncological DIagnostics and Therapy · NCT07426055
We will test whether adding a whole-gland radiation boost (with brachytherapy or a stereotactic boost) improves cancer control compared with SBRT alone in men whose prostate cancer is confined to the prostate on PSMA PET.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Affidea Nu-med Center of Oncological DIagnostics and Therapy (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Zamość, Lublin Voivodeship) |
| Trial ID | NCT07426055 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed prostate adenocarcinoma staged cT1-4, cN0, cM0 on PSMA PET who are candidates for definitive radiotherapy and have ECOG performance status 0–2 are ideal candidates.
Not a fit: Patients with pelvic nodal or distant metastases on baseline imaging, prior definitive local prostate treatment, or who are medically unfit for brachytherapy/SBRT are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the boost approach could provide better long-term cancer control and reduce the risk of recurrence for men with localized or locally advanced prostate cancer.
How similar studies have performed: Previous randomized trials (for example ASCENDE-RT) have shown brachytherapy boost can improve biochemical control versus external beam alone, but direct comparison with modern SBRT monotherapy using mandatory PSMA staging is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zamość, Lublin Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostate Brachytherapy, Stereotactic Body Radiation Therapy, Dose Escalation: Solid Tumors, Localized Prostate Cancer, Radiotherapy, Stereotactic Body Radiotherapy, SBRT