Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04777071
Other study ID # RG1007462
Secondary ID NCI-2020-0261210
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 17, 2021
Est. completion date March 31, 2028

Study information

Verified date May 2024
Source University of Washington
Contact Akshata Mathur
Phone 206.667.5801
Email psmaresearch@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.


Description:

OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening. After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.


Recruitment information / eligibility

Status Recruiting
Enrollment 213
Est. completion date March 31, 2028
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically proven prostate adenocarcinoma - For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following: - Grade group 4-5 and/or - PSA > 20 ng/mL - For patients with biochemical recurrence (biochemical recurrence cohort): - Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy) - If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence - If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence) - For patients undergoing systemic therapy (treatment monitoring cohort): - Diagnosis of metastatic castration-resistant prostate cancer - At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days - Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy - This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort) - No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed) - Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2 - Ability to understand and willingness to provide informed consent Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Design


Intervention

Procedure:
Computed Tomography
Undergo PET/CT scan
Drug:
Gallium Ga 68 Gozetotide
Given IV
Procedure:
Positron Emission Tomography
Undergo PET/CT scan
Magnetic Resonance Imaging
Undergo PET/MR scan
Bone Scan
Undergo bone scan

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in planned management strategy Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates. Baseline up to 1.5 years after the last scan
Secondary Major change in management Defined as a change in treatment modality (e.g. change from systemic therapy to radiation therapy). Will compare by planned management strategy using conventional imaging and executed management strategy incorporating information from scan 1 68Ga-PSMA-11 PET/CT, regardless of treatment modality. 95% CIs will be used to express precision of the estimates. This analysis applies to the subjects enrolled in the initial staging (N=30), biochemical recurrence (N=30), and equivocal lesions cohorts (N=43). Baseline up to 5 years post-scan
Secondary Minor change in management Defined as changes within a treatment modality (e.g. change in planned radiation field or change in systemic therapy regimen to be used for a patient already planned to receive systemic therapy). Defined as a post-scan change within a treatment modality (e.g. alteration to salvage radiation field). 95% CIs will be used to express precision of the estimates. Baseline up to 5 years post-scan
Secondary 68Ga-PSMA-11 standardized uptake value maximum (SUVmax) Changes in uptake will be compared among all groups using analysis of variance (ANOVA) or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test. Up to 6 weeks after systemic therapy initiation
Secondary 68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak) Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test. Up to 6 weeks after systemic therapy initiation
Secondary Change in 68Ga-PSMA-11 SUVmax Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test. Baseline up to 6 weeks after systemic therapy initiation
Secondary Change in 68Ga-PSMA-11 SULpeak Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test. Baseline up to 6 weeks after systemic therapy initiation
Secondary Change in size of measurable metastatic lesions Assessed by CT or magnetic resonance imaging (MRI) by RECIST 1.1 criteria. Baseline up to 5 years post-scan
Secondary Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens Will be performed only in patients with biopsy or surgical resection specimens. Lesions on each scan will be categorized as positive or negative. Pathology results will also be scored as positive or negative based on the clinical interpretation. These results will then be used to calculate accuracy with 95% CIs. CIs will be calculated using the non-parametric bootstrap with resampling by patient to account to dependence between lesions from the same patient. Up to 5 years post-scan
See also
  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
Completed NCT02940262 - Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy Phase 3
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