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

Stefan Carlsson

Status and phase: Enrolling; Phase 3

Conditions: Prostate Cancer

Treatments: Combination Product: Individualised therapy; Radiation: Standard salvage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04794777

PSMA recidiv

Details and patient eligibility

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.

Enrollment: 450 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Experimental arm

Experimental group

Description:

Individualised therapy based on results of the PSMA PET/CT.

Treatment:

Combination Product: Individualised therapy

Control arm

Active Comparator group

Description:

Standard salvage therapy. Results of PSMA PET/CT blinded.

Treatment:

Radiation: Standard salvage therapy