At a glance
ClinicalIndex Comparison Record- ✓Prior radical prostatectomy for prostate cancer
- ✓Biochemical recurrence with PSA >0.2 and <2.0 ng/mL, measured twice and increasing
- ✓Multidisciplinary conference decision to offer salvage radiotherapy
- ✓Signed informed consent
- ✕Prior androgen deprivation therapy after prostatectomy
- ✕Prior pelvic radiotherapy
- ✕Positive lymph nodes at time of surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Individualised therapy and Standard salvage therapy for Prostate Cancer. Currently recruiting, targeting 450 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed. Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND). Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND. Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention.
Standard salvage radiotherapy