Study of Psma radiopharmaceutical for diagnosis of prostate cancer recurrence

Phase 3

• Conditions: Prostate neoplasia with local or metastatic recurrence; C04.697.650; C04.697.655; C04.588.945.440.770

• Registration Number: RBR-26w4cr
• Lead Sponsor: MJM Produtos Farmaceuticos e de Radioprotecao Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Volunteer 18 years of age or older submitted to curative treatment of prostate cancer. Prostatectomy and presenting biochemical prostate cancer recurrence. Indicating PSA> 0.2 ng/ml level. Curative radiochemical therapy and presenting biochemical prostate recurrence. Indicating PSA> 2.0 ng/ml. Result of at least one of the following exams. MDP-Tc-99m bone scintigraphy. Nuclear Magnetic Resonance. Computed Tomography, or Positron Emission Tomography with Fluordeoxiglucose-F-18. Being capable of understand and sign the informed consent.

Exclusion Criteria

Radiopharmaceutical therapy administered within four weeks or in a smaller time interval than five half-lives of the used agent. Active infection or fever not explained> 38.5 ° C during screening visits or on the day of the examination. Known hypersensitivity to any of the components Ga-68. HBED-CC. PSMA or excipient of PSMAHBED DC-kit. Any other medical or social condition considered by the investigator prone to interfere with the patient's ability to sign the consent cooperate and participate in the study or interfere with the interpretation of the results.

Study & Design

• Study Type: Intervention
• Study Design: Not specified