Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Carcinoma

Prostatic Neoplasms

Recurrence

Urogenital Neoplasms

Genital Neoplasms, Male

Disease Attributes

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

Radiopharmaceuticals

Patients with BCR prostate cancer, after definitive surgery or radiation therapy, who have PSMA-positive disease and have not yet initiated lifelong hormone therapy.

Patients with PSMA-positive mCRPC who have exhausted all satisfactory or available approved treatment options.

Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles.

[Ac-225]-PSMA-62 (mCRPC)

Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles.

[Ac-225]-PSMA-62 (BCR)

Richard Cioci

ACCEL is a multicenter, open label phase I/II study of \[Ac-225\]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.

The primary aim of the phase I study is to evaluate the safety and tolerability of \[Ac-225\]-PSMA-62 to determine recommended phase II doses for patients with mCRPC and BCR prostate cancer. The aim of the phase II study for patients with mCRPC is to evaluate the efficacy of \[Ac-225\]-PSMA-62.

[Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer

[Ac-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, Tolerability, and Dosimetry in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer (ACCEL)

Treatment emergent adverse events (TEAEs) and dose limiting toxicities (DLTs) for \[Ac-225\]-PSMA-62

To assess safety and tolerability of \[Ac-225\]-PSMA-62

BCR only: Preliminary efficacy assessment

mCRPC only: Preliminary efficacy assessment based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (soft tissue) and the Prostate Cancer Working Group 3 (PCWG3) criteria (bone) per investigator review

Evaluation of the biodistribution and radiation dosimetry of \[Ac-225\]-PSMA-62 to normal organs

To determine the effect of \[Ac-225\]-PSMA-62 on prostate-specific antigen (PSA) kinetics

To determine the effect of \[Ac-225\]-PSMA-62 on patient reported outcomes (PROs) responses scored from 0 ("never", "none", "not at all") to 5 ("almost constantly", "very severe", "very much") on the frequency, severity and/or interference of symptoms related to adverse events

Eli Lilly and Company

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Antineoplastic Agents

Reproductive Control Agents

Leuprolide

Antineoplastic Agents, Hormonal

Participants will be treated with 240 mg (4-60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.

Participants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, then they will crossover to Apalutamide + IHT

Apalutamide 240 mg (4 60mg tablets) daily

Apalutamide

Leuprolide 3-month depot 22.5 intramuscular dose

Robert J Amato, DO

This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low levels of red blood cells that can make people feel tired and weak), diabetes (low blood sugar), heart disease, metabolic syndromes (sometimes called "pre-diabetes" and includes obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood), and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.

Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer.

Men will be randomized (like flipping a coin) to receive:

* Group A: Leuprolide + Apalutamide or
* Group B: Leuprolide only (until second leuprolide injection), then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long.

Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above undetectable level unless leuprolide is given without pause, every 3 months).

Prostate-specific antigen (PSA) is a sensitive and specific biomarker of prostate tissue. Monitoring of PSA after local treatment for prostate cancer can assist in identifying patients who have only increased PSA (biochemical recurrence \[BCR\]) despite no symptoms, signs, or evidence of radiographic metastatic disease. This subpopulation of patients are referred to as having "biochemical failure." Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia, diabetes, heart disease, metabolic syndromes and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given "breaks" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance, owing to the removal of constant pressure causing faster mutation of resistant cells; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug.

Apalutamide is an investigational antitumor drug, taken by mouth. It is a synthetic compound rationally designed to bind the androgen receptor (with higher affinity than enzalutamide or bicalutamide), prevent both nuclear translocation and DNA binding, and induce apoptosis. It has greater antitumor activity at a lower dose, achieves steady-state levels at a lower dose, and accumulates more into tumor tissue without building up in the brain, which both increases effectiveness and decreases the risk of seizure.

Apalutamide's mechanism of action gives it the potential to extend the time to PSA increase during intermittent ADT, delaying the necessity for continuous ADT. Investigators will assess the potential applications of intermittent ADT plus Apalutamide for participants with BCR. This study will elucidate the potential of this regimen to reduce the burden of adverse events of continuous ADT and delay the development of hormone resistance.

This is a randomized crossover study intended to determine the interval of ADT administration achievable with supportive Apalutamide treatment. Investigators will assess the significance of time to PSA recurrence, time to next leuprolide injection, time to testosterone recovery, duration of testosterone recovery, time to biochemical recurrence, percentage of men developing biochemical recurrence, number of detectable CTCs, and quality of life measures.

Treatment will be 66 participants in 2:1 randomized crossover - 45 IHT + apalutamide:21 IHT only until second leuprolide injection, then IHT + apalutamide

Apalutamide + IHT Participants will be treated with 240 mg (4 60 mg tablets) oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.

IHT Participants will receive 22.5 mg 3-month depot intramuscular leuprolide until PSA progression, when they will receive 240 mg oral Apalutamide daily plus 22.5 mg 3-month depot intramuscular leuprolide intermittently.

Participants remain on study until continuous ADT is required to maintain castrate PSA levels (i.e., leuprolide is needed every 3 months to maintain PSA \<1 ng/dL).

Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer

Apalutamide Plus Intermittent Hormone Therapy (IHT) Versus IHT Alone in Prostate Cancer Patients With Biochemical Recurrence

Time to prostate-specific antigen (PSA) nadir

Time to testosterone recovery to \>50 ng/dl

Time until BCR after discontinuation of Apalutamide and ADT

Quality of life as determined by FACT-P survey

Janssen Scientific Affairs, LLC

The University of Texas Health Science Center, Houston

Adenocarcinoma

Micronutrients

Mineral

Copper

Trace Elements

Copper Supplement

Radiopharmaceutical PET imaging tracer injected intravenously for the detection of PSMA expression.

Copper Cu 64 PSMA I&T

Darcy Denner, PhD

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

The study will include approximately 200 patients with suspected biochemically recurrant prostate cancer. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\&T injection.

The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I\&T. Analysis of the reads will be used for determination of the patient-level correct detection rate and region-level correct localization rate of copper Cu 64 PSMA I\&T PET/CT by comparison to the Reference Standard.

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

A Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Men With Biochemical Recurrence of Prostate Cancer

To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 minutes to 240 minutes post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.

To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 and 240 minutes post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.

Comparison of patient level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT stratified by Prostate-Specific Antigen level.

Comparison of patient-level CDR and region level CLR of copper Cu 64 PSMA I\&T PET/CT separated into subgroups of patients with histopathology available and unavailable.

Reader kappa statistics of copper Cu 64 PSMA I\&T PET/CT scan interpretation by the blinded independent readers.

Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
[Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer	NCT06229366	Prostate Cancer Metastatic Cast... Biochemically R...	[Ac-225]-PSMA-6... [Ac-225]-PSMA-6...	18 Years -	POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
[Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer	NCT06229366	Prostate Cancer Metastatic Cast... Biochemically R...	[Ac-225]-PSMA-6... [Ac-225]-PSMA-6...	18 Years -	POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer	NCT02811809	Prostate Cancer	Apalutamide IHT	18 Years -	The University of Texas Health Science Center, Houston
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer	NCT06235099	Prostate Cancer Prostate Adenoc... Biochemical Rec...	Copper Cu 64 PS...	18 Years -	Curium US LLC

Spots Global Cancer Trial Database for bcr

Every month we try and update this database with for bcr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bcr

Every month we try and update this database with for bcr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bcr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.