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Chemotherapy
Docetaxel + PROSTVAC for Prostate Cancer
Phase 2
Waitlist Available
Led By Ravi A Madan, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a performance status of 0 to 2 according to ECOG criteria
Patients must have metastatic disease defined as at least one lesion on bone scan or at least one measurable lesion per RECIST 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 39 weeks and 1 year
Awards & highlights
Study Summary
This trial will test if adding PROSTVAC vaccine & chemotherapy to androgen deprivation therapy can better control prostate cancer than ADT alone.
Who is the study for?
This trial is for men over 18 with metastatic castrate-sensitive prostate cancer. They must have had a physical exam, medical history review, blood tests, and possibly imaging scans like CT or MRI. Eligible participants can have had up to 24 months of ADT previously but need good organ function and performance status (able to carry out daily activities). They cannot be immunocompromised, have serious allergies related to the vaccine components or certain autoimmune diseases, uncontrolled hypertension, prior chemotherapy for prostate cancer, other active malignancies within the last two years except specific skin cancers or bladder carcinoma in situ.Check my eligibility
What is being tested?
The study is testing if adding PROSTVAC (a vaccine) and docetaxel (chemotherapy) to standard ADT improves outcomes in prostate cancer treatment compared to ADT alone. Participants are divided into two groups; both receive ADT and docetaxel but at different times relative to PROSTVAC injections. The treatments span several weeks with follow-up visits every three months for up to fifteen years.See study design
What are the potential side effects?
Possible side effects include typical reactions from vaccines such as soreness at injection site and flu-like symptoms. Docetaxel may cause hair loss, nausea/vomiting, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, neuropathy (nerve pain), allergic reactions during infusion among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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My cancer has spread and can be measured by scans.
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My blood, liver, and kidney functions are all within normal ranges.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 39 weeks and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~39 weeks and 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks
Secondary outcome measures
Antigen Specific T-cell Immune Composite Response Scores Between All Arms at 39 Weeks and 1 Year
Number of Participants With T-cell Response to Prostate-specific Antigen (PSA)
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C/ PROSTVAC Prior to DocetaxelExperimental Treatment3 Interventions
Standard androgen deprivation therapy (ADT) followed by prostvac, then docetaxel. No ADT for less than 28 days, prostvac prior to docetaxel.
Group II: Arm B/ Combined Docetaxel with PROSTVACExperimental Treatment3 Interventions
Standard androgen deprivation therapy (ADT) followed by combined docetaxel + prostvac
Group III: Arm A/Sequential Docetaxel followed by PROSTVACExperimental Treatment3 Interventions
Standard androgen deprivation therapy (ADT) followed by sequential docetaxel + prostvac
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PROSTVAC-F
2018
Completed Phase 3
~1420
PROSTVAC-V
2018
Completed Phase 3
~1320
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,593 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,099 Patients Enrolled for Prostate Cancer
Ravi A Madan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
17 Previous Clinical Trials
1,064 Total Patients Enrolled
11 Trials studying Prostate Cancer
902 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
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