Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT04794777

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

Led by Stefan Carlsson · Updated on 2025-03-20

450

Participants Needed

5

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Sahlgrenska University Hospital

Gothenburg, Göteborg, Sweden, 413 45

Actively Recruiting

2

Södersjukhuset

Stockholm, Stockholm County, Sweden, 118 83

Not Yet Recruiting

3

Karolinska University Hospital

Stockholm, Stockholm County, Sweden, 171 76

Actively Recruiting

4

Norrland's University Hospital

Umeå, Sweden, 901 85

Not Yet Recruiting

5

Örebro University Hospital

Örebro, Örebro County, Sweden, 701 85

Not Yet Recruiting

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Research Team

S

Stefan Carlsson

CONTACT

Y

Yvonne Larsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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