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Anti-androgen
Targeted Treatment for Prostate Cancer (PREDICT Trial)
Newark, DE
Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
* PRE-REGISTRATION: Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment completion, an average of one year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether genetic testing can help determine the most effective treatment for prostate cancer patients. They will analyze the DNA and RNA in cancer samples to identify mutations. The study will evaluate the effectiveness of
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Who is the study for?
Adults with prostate cancer, including those with specific variant histologies, are eligible if they have evidence of disease progression. They must have rising PSA levels or radiographic/bone metastasis progression and tissue available for genetic testing. Prior treatment with certain hormone therapies or taxane is required unless ineligible or refused by the patient.Check my eligibility
What is being tested?
The trial tests targeted treatments based on genetic abnormalities in prostate cancer cells. Treatments include various medications that inhibit tumor growth through different mechanisms, such as blocking male hormones or delivering radiation directly to tumor cells.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, hair loss from chemotherapy drugs like Carboplatin; hormonal changes from Abiraterone Acetate and Enzalutamide; nerve issues from Cabazitaxel; and radiation-related symptoms from Lutetium Lu 177 vipivotide tetraxetan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has spread to my bones and is getting worse.
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I am 18 years old or older.
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My PSA levels have been rising over time, indicating my prostate cancer is progressing.
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My prostate cancer is PSMA positive and suitable for lutetium Lu 177 treatment.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through treatment completion, an average of one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, an average of one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response
Secondary study objectives
Duration of Response
Overall Survival
Prostate-specific antigen response
+4 moreOther study objectives
National Cancer Institute PRO-CTCAE™ data
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (genetic testing, physician choice treatment)Experimental Treatment11 Interventions
Patients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Group II: Arm B (genetic testing, carboplatin, cabazitaxel)Experimental Treatment9 Interventions
Patients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Group III: Arm A (genetic testing, valemetostat tosylate)Experimental Treatment8 Interventions
Patients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6450
Abiraterone Acetate
2015
Completed Phase 4
~1780
Computed Tomography
2017
Completed Phase 2
~2440
FDG-Positron Emission Tomography
2017
Completed Phase 2
~20
PSMA PET Scan
2020
N/A
~10
Enzalutamide
2014
Completed Phase 4
~3820
Bone scan
2015
Completed Phase 2
~250
Valemetostat Tosylate
2019
Completed Phase 2
~30
Biospecimen Collection
2004
Completed Phase 3
~1810
Cabazitaxel
2014
Completed Phase 3
~1290
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Find a Location
Closest Location:Helen F Graham Cancer Center· Newark, DE
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,068 Previous Clinical Trials
41,159,657 Total Patients Enrolled
519 Trials studying Prostate Cancer
333,931 Patients Enrolled for Prostate Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
520 Previous Clinical Trials
223,334 Total Patients Enrolled
29 Trials studying Prostate Cancer
5,836 Patients Enrolled for Prostate Cancer
Rana McKay, MDStudy ChairAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Prostate Cancer
50 Patients Enrolled for Prostate Cancer