Prostate Adenocarcinoma Clinical Trial
Official title:
68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy
This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.
PRIMARY OBJECTIVE: I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. SECONDARY OBJECTIVES: I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard). II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only. III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0). IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients. V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging. After completion of study, patients are followed up for 3-12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03796767 -
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
|
Phase 2 | |
| Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
| Completed |
NCT05735223 -
A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy on the Stretched Flaccid Penile Length and Continence
|
N/A | |
| Recruiting |
NCT04175431 -
Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
|
Phase 2 | |
| Completed |
NCT05197257 -
68Ga-PSMA-11 PET in Patients With Prostate Cancer
|
Phase 3 | |
| Withdrawn |
NCT03982173 -
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors
|
Phase 2 | |
| Terminated |
NCT02491411 -
Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel
|
N/A | |
| Active, not recruiting |
NCT02254746 -
A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
|
N/A | |
| Active, not recruiting |
NCT05496959 -
177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study
|
Phase 2 | |
| Recruiting |
NCT04391556 -
Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma
|
Phase 2 | |
| Enrolling by invitation |
NCT03503643 -
Hemi-Gland Cryoablation for Prostate Cancer at UCLA
|
||
| Recruiting |
NCT05832086 -
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
|
Phase 2 | |
| Suspended |
NCT05064111 -
Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy
|
||
| Not yet recruiting |
NCT04031378 -
Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT02600156 -
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
|
N/A | |
| Recruiting |
NCT05726292 -
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT04423211 -
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
|
Phase 3 | |
| Terminated |
NCT03718338 -
Mechanisms of Metabolic and Hormone Action on Plaque Formation in Brain and Carotid Vessels in Patients With Prostate Adenocarcinoma
|
||
| Terminated |
NCT02564549 -
MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca
|
N/A | |
| Recruiting |
NCT04983862 -
Fluorescent Imaging of Nerves With Illuminare-1 During Surgery
|
Phase 1 |