Prospective evaluation of 68-Ga-PSMA-PET and early PSA kinetics during salvage radiotherapy for personalizing the management of men with relapse of prostate cancer after radical prostatectomy.

Prospective evaluation of 68-Ga-PSMA-PET and early PSA kinetics during salvage radiotherapy for personalizing the management of men with relapse of prostate cancer after radical prostatectomy. - PROPER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004425-13-SE

Enrollment

100

Registered

2015-12-10

Start date

2016-01-22

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Patients with prostate cancer, with a PSA recurrence of ? 0.2 ng/ml after prostatectomy, and who are going to receive radiotherapy to the prostate bed. MedDRA version: 18.1 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 100000004864

Interventions

Product Name: 68-Ga-PSMA Pharmaceutical Form: Radiopharmaceutical precursor Current Sponsor code: 68GA-PSMA Other descriptive name: 68GA-PSMA HBED-CC Concentration unit: MBq/kg megabecquerel(s)/kilogr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Confirmed prostate cancer - PSA recurrence after prostatectomy (defined as a PSA ? 0.2 ng/ml confirmed in a second sample) - Expected Life-expectancy of ? 10 years - Any pT, pN0/X, M0/X - Patients suitable for radiotherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Previous malignancy other than basalioma within the last 5 years - Previous or ongoing hormonal therapy - Inability to sign written informed concent

Design outcomes

Primary

Measure	Time frame
Main Objective: The ability of 68-Ga-PSMA-PET to identify relapse of prostate cancer in patients with recurrence after prostatectomy.;Secondary Objective: - PSA response (during treatment) - PSA response (at 3, 6, 9, 12, and 24 months post treatment - Overall survival - Toxicity - Quality of life - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of distant metastases (68-Ga-PSMA-PET/m-MRT) in the salvage setting - Prevalence of local recurrent disease (68-Ga-PSMA-PET) in the salvage setting - Time to hormone therapy/chemotherapy ;Primary end point(s): The ability of 68-Ga-PSMA-PET to identify prostate cancer recurrence in patients with biochemical relapse after prostatectomy.;Timepoint(s) of evaluation of this end point: After 5 weeks of radiotherapy.	—

Measure

Time frame

Main Objective: The ability of 68-Ga-PSMA-PET to identify relapse of prostate cancer in patients with recurrence after prostatectomy.;Secondary Objective: - PSA response (during treatment) - PSA response (at 3, 6, 9, 12, and 24 months post treatment - Overall survival - Toxicity - Quality of life - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of distant metastases (68-Ga-PSMA-PET/m-MRT) in the salvage setting - Prevalence of local recurrent disease (68-Ga-PSMA-PET) in the salvage setting - Time to hormone therapy/chemotherapy ;Primary end point(s): The ability of 68-Ga-PSMA-PET to identify prostate cancer recurrence in patients with biochemical relapse after prostatectomy.;Timepoint(s) of evaluation of this end point: After 5 weeks of radiotherapy.

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Secondary

Measure	Time frame
Secondary end point(s): - PSA response (during treatment) - PSA response (at 3, 6, 9, 12, and 24 months post-treatment) - Overall survival - Toxicity - Quality of Life - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of distant metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of local recurrent disease (68-Ga-PSMA-PET/m-MRT) in the salvage setting - Time to hormone therapy/chemotherapy;Timepoint(s) of evaluation of this end point: - PSA evaluation weekly during radiotherapy - Evaluation with 68-Ga-PSMA-PET after 5 weeks of radiotherapy - PSA evaluation at 3, 6, 9, 12 months after end of radiotherapy, thereafter every 6 months until progressive disease. - Evaluation of quality of life before start of treatment, at end of radiotherapy, and at 1 year after end of radiotherapy	—

Measure

Time frame

Secondary end point(s): - PSA response (during treatment) - PSA response (at 3, 6, 9, 12, and 24 months post-treatment) - Overall survival - Toxicity - Quality of Life - Prevalence of lymph node metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of distant metastases (68-Ga-PSMA-PET) in the salvage setting - Prevalence of local recurrent disease (68-Ga-PSMA-PET/m-MRT) in the salvage setting - Time to hormone therapy/chemotherapy;Timepoint(s) of evaluation of this end point: - PSA evaluation weekly during radiotherapy - Evaluation with 68-Ga-PSMA-PET after 5 weeks of radiotherapy - PSA evaluation at 3, 6, 9, 12 months after end of radiotherapy, thereafter every 6 months until progressive disease. - Evaluation of quality of life before start of treatment, at end of radiotherapy, and at 1 year after end of radiotherapy

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Countries

Sweden

Contacts

Public ContactDepartment of Oncology

Skåne University Hospital

adalsteinn.gunnlaugson@skane.se+464617 75 20

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026