A Randomized Trial Comparing Conventional Salvage Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery

Who is this study for? Adult patients with prostate cancer
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Radiation, Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Örebro University Hospital
NOT_YET_RECRUITING
Örebro
Karolinska University Hospital
RECRUITING
Stockholm
Södersjukhuset
NOT_YET_RECRUITING
Stockholm
Norrland's University Hospital
NOT_YET_RECRUITING
Umeå
Contact Information
Primary
Stefan Carlsson
stefan.carlsson@ki.se
0704871106
Backup
Yvonne Larsen
yvonne.larsen@regionstockholm.se
Time Frame
Start Date: 2018-10-30
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 450
Treatments
Experimental: Experimental arm
Individualised therapy based on results of the PSMA PET/CT.
Active_comparator: Control arm
Standard salvage therapy. Results of PSMA PET/CT blinded.
Related Therapeutic Areas
Sponsors
Leads: Stefan Carlsson

This content was sourced from clinicaltrials.gov