Condition: Prostate Cancer (Adenocarcinoma), Prostate Brachytherapy, Stereotactic Body Radiation Therapy (SBRT), Dose Escalation: Solid Tumors, Localized Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07426055

Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy

Phase: Phase 2/Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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.

View trial on ClinicalTrials.gov