Clinical trial NCT04794777: Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: PSMA PET/CT
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Primary PSA progression free survival
timeFrame: Throughout the study, approximately 10 years.
Secondary outcomes:
measure: Time to metastasis
timeFrame: At 5, 7 and 10 years
measure: Prostate cancer specific survival
timeFrame: At 5, 7 and 10 years
measure: Time to secondary treatment
timeFrame: At 5, 7 and 10 years
measure: Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)
timeFrame: Baseline, 6, 12, 36 and 60 months after completed treatment.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Norrland's University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Stefan Carlsson
role: PRINCIPAL_INVESTIGATOR
References: