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โ† Trials
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PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer

RecruitingPhase 2, Phase 3Ages 18 Years - anyMaleAffidea Nu-med Center of Oncological DIagnostics โ€ฆ
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In plain words

What the trial is, and whether it could suit you

PRO-BOOST-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT). Radiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PE

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male patients aged โ‰ฅ18 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.
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What it tests

  • Stereotactic Body Radiotherapy (SBRT) Monotherapy
  • External Beam Radiotherapy (EBRT) Backbone
  • High-Dose-Rate Brachytherapy Boost
  • Low-Dose-Rate Brachytherapy Boost
  • Stereotactic Body Radiotherapy (SBRT) Boost
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Where

1 site
Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
Zamoล›ฤ‡, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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