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.

• 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: 18.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004425-13-SE
• Lead Sponsor: Skåne University Hospital, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-10
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified