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Hormone Therapy
Combination Therapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Jingsong Zhang, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion
ECOG performance status of 0-1
Must not have
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
Prior prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 36 months
Awards & highlights
Summary
This trial is testing a new way to treat high risk prostate cancer that may be more effective than current methods.
Who is the study for?
This trial is for men with high-risk, stage IV prostate cancer who haven't had extensive prior treatments. They should be relatively healthy (ECOG 0-1), have not used certain hormone therapies recently, and must agree to use contraception. Men with uncontrolled heart issues, recent investigational drugs, brain metastases, or autoimmune diseases are excluded.
What is being tested?
The study tests if starting treatment with hormonal therapy (LHRH analog plus a new agent like abiraterone) followed by chemotherapy (docetaxel) improves outcomes in advanced prostate cancer. Participants will first receive the hormonal therapy then move on to chemohormonal therapy.
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from docetaxel; hot flashes and bone thinning from LHRH analogs; and liver issues or high blood pressure from new hormonal agents. Tislelizumab may cause immune-related reactions affecting various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis was confirmed through a biopsy.
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I am fully active or can carry out light work.
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My prostate cancer is high risk with a Gleason score of 8+, 3+ bone metastases, or visceral metastasis.
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My blood counts and kidney and liver functions are within normal ranges.
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I have been diagnosed with prostate cancer through a biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of lung conditions like interstitial lung disease or pulmonary fibrosis.
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I have had surgery to remove my prostate.
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I have been treated with a PD-1 or PD-L1 inhibitor before.
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I have brain metastases confirmed by tests.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have been treated with specific prostate cancer medications for over 8 weeks.
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I have wounds, ulcers, or bone fractures that are healing slowly.
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I do not have HIV/AIDS or I am not on antiretroviral therapy.
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I have not received a live vaccine in the last 4 weeks.
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I am allergic to certain chemotherapy drugs or hormone therapy medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
PSA <0.2 nanogram per milliliter (ng/ml) rate at 12 months
PSA <0.2 nanogram per milliliter (ng/ml) rate at 36 months
PSA <0.2 nanogram per milliliter (ng/ml) rate at 6 months
+2 moreOther study objectives
Comparison of Standard Uptake Values (SUV)
Trial Design
1Treatment groups
Experimental Treatment
Group I: First Strike then Second StrikeExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4560
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
BeiGeneIndustry Sponsor
188 Previous Clinical Trials
30,053 Total Patients Enrolled
1 Trials studying Prostate Cancer
108 Patients Enrolled for Prostate Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,508 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,153 Patients Enrolled for Prostate Cancer
Jingsong Zhang, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
56 Total Patients Enrolled
1 Trials studying Prostate Cancer
26 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung conditions like interstitial lung disease or pulmonary fibrosis.I have had surgery to remove my prostate.My prostate cancer diagnosis was confirmed through a biopsy.I have been treated with a PD-1 or PD-L1 inhibitor before.I haven't had any other cancer besides non-melanoma skin cancer or in situ carcinoma, or if I did, it was over 2 years ago and fully treated.I am fully active or can carry out light work.My prostate cancer is high risk with a Gleason score of 8+, 3+ bone metastases, or visceral metastasis.I have brain metastases confirmed by tests.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I do not have an active infection like TB, hepatitis B, or C.I have been treated with specific prostate cancer medications for over 8 weeks.I can understand and am willing to sign the consent form myself or have someone legally authorized to do so on my behalf.My heart functions well despite a history of heart issues, with an ejection fraction over 40%.I have wounds, ulcers, or bone fractures that are healing slowly.I do not have HIV/AIDS or I am not on antiretroviral therapy.I have or had an autoimmune or inflammatory disorder like Crohn's disease or lupus.I have not received a live vaccine in the last 4 weeks.I am allergic to certain chemotherapy drugs or hormone therapy medications.My blood counts and kidney and liver functions are within normal ranges.I am a man who meets the trial's criteria.I haven't been on hormone therapy for prostate cancer for more than 12 weeks.I am a man who meets the trial's criteria, regardless of my race or ethnicity.I have been diagnosed with prostate cancer through a biopsy.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: First Strike then Second Strike
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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