Comparing "salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in with Relapsing Prostate Cancer

Last updated: March 17, 2025
Sponsor: Stefan Carlsson
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Individualised therapy

Standard salvage therapy

Clinical Study ID

NCT04794777
PSMA recidiv
  • Ages > 18
  • Male

Study Summary

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 limited data of its impact.

In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients previously treated for prostate cancer with radical prostatectomy and nowhaving a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, andincreasing measured twice.

  • Multidisciplinary conference (MDK) decision to offer the patient SRT

  • Signed Informed Consent

Exclusion

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

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Individualised therapy
Phase: 3
Study Start date:
October 30, 2018
Estimated Completion Date:
October 30, 2027

Connect with a study center

  • Sahlgrenska University Hospital

    Göteborg, 413 45
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Södersjukhuset

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Norrland's University Hospital

    Umeå, 901 85
    Sweden

    Site Not Available

  • Örebro University Hospital

    Örebro, 701 85
    Sweden

    Site Not Available

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