Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Androgens

Hormones

Hormone Antagonists

Participants will receive Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD).

Radium-223 is an alpha-particle-emitting bone-targeted therapy. All patients will receive Treatment with Radium-223 at a dose of 55 kBq per kilogram of body weight IV every 28 days, for 6 cycles,

radium-223

All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.

Bipolar Androgen Therapy (BAT)

Rana Sullivan, RN

Amber Michalik, BA

Pedro Isaacsson Velho, M,D

Samuel Denmeade, M,D

This is a single-arm, multicenter open label, international, phase II study of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) in men with metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC with progressive disease (radiographically and/or biochemically) who have been treated with gonadotropin-releasing hormone (GnRH)-analogue (LHRH agonists/antagonists) continuously or bilateral orchidectomy will be enrolled in this study. Previous antiandrogen therapies are permitted, but no more than one (such as abiraterone, enzalutamide, apalutamide, darolutamide). All patients will receive treatment with Radium-223 at a dose of 55 Kilobecquerel (kBq) per kilogram of body weight IV every 28 days, for 6 cycles, plus Testosterone Cypionate 400mg Intramuscular (IM) every 28 days, until progression or unacceptable toxicity.

Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (BAT-RAD Study)

To estimate the percentage of patients with somatic (tumor) or germline (inherited) mutations in homologous repair (HR) and/or mismatch repair (MMR) genes in patients with mCRPC.

To determine the radiographic progression-free survival (rPFS) of BAT-RAD in patients with mCRPC treated with at least one novel androgen receptor (AR) targeted treatment.

To determine the PSA decline ≥ 50% rate (PSA50) of BAT-RAD in patients with mCRPC in 24 months.

To determine if the dynamics (change) of alkaline phosphatase of BAT-RAD in patients with mCRPC.

To determine the PSA progression-free survival (PSA-PFS) of BAT-RAD in patients with mCRPC in 24 months.

To determine the time to disease progression of BAT-RAD in patients with mCRPC measured in months.

To determine the overall survival of BAT-RAD in patients with mCRPC in 24 months.

To determine the symptomatic skeletal event-free survival in patients with mCRPC in 24 months.

The EQ-5D-3L is made up of 5 questions each with 3 levels. The lowest level being none and the highest level being extreme. Overall score range of 3-15 with higher scores signifying worse quality of life.

The (FACT-P) is made up of 39 question the scoring is between 0 and 156 with 0 being the best and 156 as the worst.

The Brief Pain Inventory-Short Form (BPI-SF) is 1 question 0 being the best and 10 being the worst.

To determine the safety of BAT-RAD in patients with mCRPC in patients with mCRPC compared with standard of care treatment for this patient population. This will be measured through Physical assessment, adverse events and labs and will be measured by how many patients are removed for adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)	NCT04704505	Prostate Adenoc... Metastatic Pros... Castration-resi...	radium-223 Bipolar Androge...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)	NCT04704505	Prostate Adenoc... Metastatic Pros... Castration-resi...	radium-223 Bipolar Androge...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for bipolar androgen therapy (bat)