Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Tislelizumab

Docetaxel

Leuprolide

Relugolix

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Tubulin Modulators

Antimitotic Agents

Hormone Antagonists

Antineoplastic Agents, Immunological

Antineoplastic Agents, Hormonal

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Androgens

Androgen Antagonists

The first part of the study treatment or "first strike" involves 12-18 weeks of combined therapy with LHRH analog and one of the new hormonal agents (NHAs). Participants will complete the "first strike" at week 13 if their PSA has reduced \>90%; otherwise they will complete a total of 18 weeks of therapy. The second part of the treatment or "second strike" involves 4 cycles docetaxel and LHRH analog. The "second strike" will start immediately after the "first strike". MRI guided prostate biopsy will be performed after "second strike". For patients with positive prostate biopsy or detectable PSA, the "second strike" will be consolidated with 4-6 additional cycles of docetaxel plus 6 doses of tislelizumab at 200 mg, given IV once every 3 weeks. For patients with undetectable PSA at year 3 from study enrollment, LHRH analog can be discontinued.

During the first strike, LHRH will be administered for 12 to 18 weeks. During the second strike, participants will receive 4 cycles of LHRH

Luteinizing Hormone Releasing Hormone

During the first strike, if Abiraterone is chosen 1000mg of Abiraterone will be taken orally. If Enzalutamide is used, 160 mg will be taken orally every 24 hours.

New Hormonal Agent

During the second strike, participants will receive 4 cycles of Docetaxel at 75mg/m2 given intravenously at day 1 of ever 21 days. For participants with positive prostate biopsy or detectable PSA, the "second strike" will receive 2 additional cycles of docetaxel.

During the second strike, participants will receive 6 doses of Tislelizumab at 200 mg, given intravenously once every 3 weeks.

Jazlyn Heiligh

Jingsong Zhang, MD, PhD

The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) followed by chemohormonal therapy with docetaxel and LHRH analog would improve the outcome of high risk metastatic/stage IV prostate cancer.

First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer

A Phase IIA Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for High Risk Metastatic Castration Sensitive Prostate Cancer

Overall survival will be from initiation of first strike until failure or death from any cause.

Investigators will measure the PSA \<0.2 nanogram per milliliter (ng/ml) at 6 months from the initiation of the first strike

Investigators will measure the PSA \<0.2 nanogram per milliliter (ng/ml) at 12 months from the initiation of the first strike

Investigators will measure the PSA \<0.2 nanogram per milliliter (ng/ml) at 36 months from the initiation of the first strike

Time to PSA progression from the initiation of "first strike"

Investigators will measure the radiographic progression free survival rate at 36 months from the initiation of "first strike"

BeiGene

H. Lee Moffitt Cancer Center and Research Institute

Symptoms and General Pathology

Hot Flashes

Herbal and Botanical

Angelica

Dong Quai

Angelica Sinensis

Hassan Razvi, MD, FRCSC

Men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. These so-called hot flashes are similar to those experienced by women during menopause. A traditional Chinese herbal preparation, Dong Quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. Anecdotal evidence exists to support the use of Dong Quai in men treated with androgen deprivation therapy for prostate cancer.

Recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. This trial was, therefore, designed to determine if Dong Quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.

Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer

Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer

St. Joseph's Health Care London

Lawson Health Research Institute

Dr. Hassan Razvi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer	NCT05189457	Prostate Cancer Stage IV Prosta...	Luteinizing Hor... New Hormonal Ag... Docetaxel Tislelizumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Angelica Sinensis for the Treatment of Hot Flashes in Men Undergoing LHRH Therapy for Prostate Cancer	NCT00199485	Prostate Cancer	Angelica Sinens...	-	Lawson Health Research Institute

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