Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Prostatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Anti-Infective Agents

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Bone Density Conservation Agents

Amino Acids

Gallium 68 PSMA-11

Androgens

Carbamide Peroxide

Edetic Acid

Pentetic Acid

Chelating Agents

Calcium

Calcium, Dietary

Radiopharmaceuticals

Lysine

Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Computed Tomography

Gallium Ga 68 Gozetotide

Positron Emission Tomography

Jeremie Calais

This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.

PRIMARY OBJECTIVE:

I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).

SECONDARY OBJECTIVES:

I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics.

II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation \[PROMISE\] criteria) under ARSI.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study

Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.

Comparison of 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes over time to PSA kinetics under ARSI. Will use mixed effects regression models to correlate the PSMA and PSA time trends. These models will include the effect of time and the PSMA by time interaction effect.

Correlation between 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes and time of bPFS under ARSI. Will utilize Cox-proportional hazards regression models. PSMA results will be treated as a time dependent covariate in these models.

Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.

Will utilize mixed effects regression models to evaluate the change in staging over time.

Assessed by Common Terminology Criteria for Adverse Events 4.03.

Jonsson Comprehensive Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Recurrence

Disease Progression

Technetium Tc 99m Medronate

Patients receive gallium Ga 68 gozetotide IV. After 50-100 minutes, patients undergo whole body PET/CT.

Jeremie Calais, MD

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

PRIMARY OBJECTIVE:

I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.

SECONDARY OBJECTIVES:

I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.

II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).

III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.

68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT

68Ga-PSMA-11 PET will be compared to bone scan/CT for M1b disease in prostate cancer patients progressing during androgen deprivation therapy. Patients who have at least one positive bone lesion will be rated positive. Patients will be treated as binary categorization. The analysis of the primary objective will utilize the McNemar's test to compare the detection rate between the imaging techniques.

Will be compared using a paired samples t-test.

Will be compared between the two modalities, defined as the number of patients with positive finding(s) for M1 disease (M1a or M1b or M1c), will utilize the McNemar's test for paired proportions.

Per-patient PPV estimates (with 95% confidence interval), defined as the number true positive findings the total number of positive cases (TP + FP). The lesions will be considered true positive on the basis of biopsy information, follow-up imaging, or changes in prostate specific antigen (PSA) levels. This information will only be available in a small subset of patients.

Univariate Cox proportional hazards models for PFS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.

Univariate Cox proportional hazards models for OS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.

Assessed using Common Terminology Criteria for Adverse Events version 4.03.

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Image Guided Biopsy

Ankush Sachdeva

Johannes Czernin, MD

Johannes Czernin

This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.

PRIMARY OBJECTIVE:

I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with molecular and cellular alterations in tumor, immune and stromal cells after radioligand therapy assessed by histopathology/immunohistochemistry, ribonucleic acid (RNA)-sequencing and proteomic/phospho-proteomic analyses of biopsy samples.

SECONDARY OBJECTIVE:

I. Sequencing to identify frequently mutated genes.

OUTLINE:

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy

Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer	NCT04279561	Castration-Resi... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Computed Tomogr... Gallium Ga 68 G... Positron Emissi...	18 Years -	Jonsson Comprehensive Cancer Center
68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy	NCT04928820	Biochemically R... Metastatic Mali... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Computed Tomogr... Gallium Ga 68 G... Positron Emissi...	18 Years -	Jonsson Comprehensive Cancer Center
Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy	NCT05398302	Castration-Resi... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Image Guided Bi...	-	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage iv prostate cancer american joint committee on cancer (ajcc) v8