Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
About this study
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.
- Condition
- Prostate Cancer
- Tested
- Individualised therapy, Standard salvage therapy
- Sponsor
- Stefan Carlsson
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 4
- 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
Where
5 sites, 5 recruiting
Sahlgrenska University Hospital
Gothenburg, Göteborg, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Örebro University Hospital
Örebro, Örebro County, Sweden
Södersjukhuset
Stockholm, Stockholm County, Sweden
Norrland's University Hospital
Umeå, Sweden
Contact
-
Stefan Carlsson
0704871106 stefan.carlsson@ki.se
-
Yvonne Larsen
Potential match only. Final eligibility is determined by the study team.