Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Adenocarcinoma

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Reproductive Control Agents

Androgens

Prednisone

Glucocorticoids

Leuprolide

Testosterone

Goserelin

Triptorelin Pamoate

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants will undergo 12-16 weeks of GnRH analog, along with 8-12 weeks of combinational therapy with GnRH analog and abiraterone plus prednisone. 14 participants who achieve \>75% PSA decline after the run-in period will be enrolled. GnRH analog and abiraterone will be stopped after study enrollment. PSA and testosterone level will be measured every 4 weeks during the run-in period, then every 6 weeks after study enrollment. Imaging studies with CT and bone scan will be performed at the time of study enrollment and these will be considered baseline scans. Study treatment will be restarted if participant's PSA reaches 2 fold or higher of his baseline PSA. Selection of treatment will be based on participant's testosterone level.

ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.

Adaptive Androgen Deprivation Therapy (ADT)

Abiraterone

Abiraterone 1000 mg daily with empty stomach.

Jingsong Zhang, M.D., Ph.D.

Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).

Investigators proposed this pilot feasibility study to use prostate specific antigen (PSA) response and testosterone level to guide the treatment with androgen deprivation therapy (ADT) \[Leuprolide, Goserelin, and Triptorelin are the most commonly used GnRH agonists for ADT\] and/or abiraterone plus prednisone. Adaptive therapy is a program of chemotherapy where the type and dosage of drug changes in an attempt to kill more of the cancer.

Abiraterone acetate with prednisone is a standard of care treatment for mCRPC (metastatic castration resistant prostate cancer). It works by interrupting the male hormone (androgen) making process in the testes, adrenal glands, and tumors. This helps to prevent the growth of tumors that need these hormones to grow.

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer

Percentage of participants who remain on study at month 12. The study will be terminated early if 2 or more of the first 6 enrolled subjects discontinued study due to cancer progression within a year of study enrollment.

Median time to prostate specific antigen (PSA) progression while on androgen deprivation therapy (ADT), abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).

Median time to radiographic progression while on ADT, abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer	NCT03511196	Prostate Cancer Stage IV Prosta... Advanced Prosta... Adenocarcinoma ...	Adaptive Androg... Abiraterone Prednisone	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer	NCT03511196	Prostate Cancer Stage IV Prosta... Advanced Prosta... Adenocarcinoma ...	Adaptive Androg... Abiraterone Prednisone	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for advanced castration sensitive prostate cancer