A Phase 3 interventional study of Individualised therapy and Standard salvage therapy in Prostate Cancer, sponsored by Stefan Carlsson. Recruiting at 5 sites in Sweden. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Stefan Carlsson · Phase 3, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 450 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Stefan Carlsson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individualised therapy based on results of the PSMA PET/CT.
Combination Product: Individualised therapy
Standard salvage therapy. Results of PSMA PET/CT blinded.
Radiation: Standard salvage therapy
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
Primary PSA progression free survival
Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement
Time frame: Throughout the study, approximately 10 years.
Time to metastasis
Time to documented metastasis of prostate cancer
Time frame: At 5, 7 and 10 years
Prostate cancer specific survival
Time to prostate cancer specific death
Time frame: At 5, 7 and 10 years
Time to secondary treatment
Time to need for secondary treatment for prostate cancer
Time frame: At 5, 7 and 10 years
Differences in quality of life recorded using Patient Reported Outcome Measure (PROM)
A modified version of the PSMA questionnaire developed by the National Prostate Cancer Register. Scale from 1 to 5 were 1 is very good and 5 is very bad.
Time frame: Baseline, 6, 12, 36 and 60 months after completed treatment.
Plan to share: No
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