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Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer

RecruitingPhase 3Ages 18 Years - anyMaleStefan Carlsson
NCT04794777 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT. Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is li

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA \>0.2 \<2.0 ng/mL, and increasing measured twice. * Multidisciplinary conference (MDK) decision to offer the patient SRT * Signed Informed Consent Exclusion Criteria: * Patients previously treated for prostate cancer with biochemical recurrence * Previous treatment with androgen deprivation therapy (ADT) after surgery * Previous pelvic radiotherapy * Patients with positive lymph nodes at surgery
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What it tests

  • Individualised therapy
  • Standard salvage therapy
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Where

5 sites
Sahlgrenska University Hospital
Gothenburg, Sweden
Södersjukhuset
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Norrland's University Hospital
Umeå, Sweden
Örebro University Hospital
Örebro, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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