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A randomized trial comparing conventional "salvage" radiotherapy and individualized PSMA-PET/CT targeted treatment in patients with biochemical recurrence after prostate cancer surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504917-54-00
Acronym
PSMA study
Enrollment
450
Registered
2023-05-25
Start date
2018-10-30
Completion date
Unknown
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biochemical recurrence after prostate cancer surgery

Brief summary

Primary PSA progression free survival (PFS) defined as documented biological progression: No response to SRT: the PSA value 3 months after completion of SRT is ≥ 0.1 ng/mL higher than the PSA value just before radiotherapy. Progression after initial response to SRT: Two rising PSA values ≥ 0.1 ng/mL after completion of radiotherapy, with the last value ≥ 0.2 ng/mL.

Detailed description

Time to metastasis, Prostate cancer specific survival, Overall survival, Time to secondary treatment: Time from randomization to start of secondary treatment, usually hormonal treatment, Quality of life: All patients fill in PSMA-PROM, a study modified quality of life questionnaire developed by the National PCa Register at baseline and 6, 12, 36, and 60 months after completed treatment.

Interventions

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary PSA progression free survival (PFS) defined as documented biological progression: No response to SRT: the PSA value 3 months after completion of SRT is ≥ 0.1 ng/mL higher than the PSA value just before radiotherapy. Progression after initial response to SRT: Two rising PSA values ≥ 0.1 ng/mL after completion of radiotherapy, with the last value ≥ 0.2 ng/mL.

Secondary

MeasureTime frame
Time to metastasis, Prostate cancer specific survival, Overall survival, Time to secondary treatment: Time from randomization to start of secondary treatment, usually hormonal treatment, Quality of life: All patients fill in PSMA-PROM, a study modified quality of life questionnaire developed by the National PCa Register at baseline and 6, 12, 36, and 60 months after completed treatment.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026