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Antibody-Drug Conjugate
Sacituzumab Govitecan for Metastatic Castration-Resistant Prostate Cancer
Phase 2
Recruiting
Led By Joshua Lang, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study treatment start. Subjects on LHRH agonists/antagonists must remain on these agents for the duration of the study
Normal organ function with acceptable initial laboratory values within 30 days of study treatment start: WBC ≥3000/μl, ANC ≥1000/μl, Platelet count ≥100,000/μl, HGB ≥9 g/dL, Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin levels of <2.0 mg/dl, Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from start of treatment
Awards & highlights
Study Summary
This trial will test a new cancer drug, IMMU-132, on men with prostate cancer that has spread and is resistant to hormone therapy.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has worsened despite treatment like enzalutamide or abiraterone. They should have no other recent cancers, not had certain treatments recently, and must be in fairly good health with stable heart conditions. Participants need a biopsy available from their cancer and agree to use two forms of birth control if applicable.Check my eligibility
What is being tested?
The trial is testing Sacituzumab Govitecan for safety and effectiveness in men whose prostate cancer has spread and isn't responding to second-generation AR-directed therapies. The study includes those who've progressed on drugs such as enzalutamide or abiraterone.See study design
What are the potential side effects?
Sacituzumab Govitecan can cause side effects including nausea, diarrhea, fatigue, hair loss, lower blood cell counts increasing infection risk, allergic reactions during infusion, liver problems (elevated liver enzymes), and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery to remove my testicles or have been on hormone therapy for prostate cancer for at least 3 months.
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My blood, liver, and kidney tests are within normal ranges.
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My prostate cancer was confirmed by a lab test.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has worsened despite treatment with specific prostate cancer medications.
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My scans show cancer has spread to my bones or other areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-Month Median Progression Free Survival
PSA response rate
Secondary outcome measures
Median Overall Survival
Median Progression Free Survival Rate
Radiologic Response Rate
+1 moreSide effects data
From 2020 Phase 3 trial • 529 Patients • NCT0257445540%
Fatigue
30%
Nausea
27%
Anaemia
25%
Neutropenia
23%
Constipation
21%
Decreased appetite
20%
Neutrophil count decreased
18%
Cough
18%
Dyspnoea
17%
Diarrhoea
16%
Alopecia
16%
Vomiting
13%
Hypokalaemia
13%
Headache
13%
Back pain
13%
Asthenia
12%
Pyrexia
12%
Aspartate aminotransferase increased
11%
Oedema peripheral
11%
Neuropathy peripheral
10%
Alanine aminotransferase increased
10%
White blood cell count decreased
8%
Urinary tract infection
8%
Myalgia
8%
Pain in extremity
7%
Platelet count decreased
7%
Arthralgia
7%
Dizziness
7%
Abdominal pain
7%
Weight decreased
6%
Mucosal inflammation
6%
Lymphocyte count decreased
6%
Bone pain
6%
Hypomagnesaemia
6%
Hypertension
6%
Thrombocytopenia
6%
Stomatitis
5%
Insomnia
5%
Pain
5%
Rash
5%
Blood alkaline phosphatase increased
5%
Hyperglycaemia
4%
Oropharyngeal pain
4%
Hypophosphataemia
4%
Anxiety
4%
Abdominal pain upper
4%
Breast pain
3%
Upper respiratory tract infection
3%
Musculoskeletal chest pain
3%
Dysgeusia
3%
Lymphoedema
3%
Pruritus
3%
Pleural effusion
3%
Gastrooesophageal reflux disease
3%
Chills
2%
Nasopharyngitis
2%
Hypocalcaemia
2%
Febrile neutropenia
2%
Sepsis
2%
Pneumonia
1%
Nasal congestion
1%
Dyspnoea exertional
1%
Dry skin
1%
Rash maculo-papular
1%
Pericardial effusion
1%
Pulmonary embolism
1%
Respiratory failure
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment of Physician's Choice (TPC)
Sacituzumab Govitecan
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan TreatmentExperimental Treatment1 Intervention
Subjects enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the subject's body weight at the beginning of each cycle or more frequently if weight changes >10%. Subjects will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,951 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,040 Patients Enrolled for Prostate Cancer
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,424 Total Patients Enrolled
1 Trials studying Prostate Cancer
200 Patients Enrolled for Prostate Cancer
University of Wisconsin, MadisonLead Sponsor
1,187 Previous Clinical Trials
3,169,442 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,911 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have serious heart rhythm problems or I have a pacemaker if I do.I have not had a recent heart attack or severe heart failure in the last 6 months.I do not have active HIV, Hepatitis B, or Hepatitis C infections.I have had surgery to remove my testicles or have been on hormone therapy for prostate cancer for at least 3 months.My blood, liver, and kidney tests are within normal ranges.I haven't used herbal or alternative therapies that affect PSA levels or fight prostate cancer in the last 4 weeks.My prostate cancer was confirmed by a lab test.I am currently on specific prostate cancer treatments but not in a combination trial.I have not had a fainting spell or mini-stroke in the last year.I received palliative radiotherapy less than 4 weeks ago.My blood pressure is not well controlled, or I've had a severe hypertension crisis before.I am 18 years old or older.I have prostate cancer that has spread to my brain but have been treated and stable for over 4 weeks without steroids.I have not had any cancer other than non-melanoma skin cancer in the past 3 years.I finished Provenge treatment less than 30 days ago.I am fully active or can carry out light work.I have diabetes and had more than 2 ketoacidosis episodes in the last year.My cancer has worsened despite treatment with specific prostate cancer medications.I've had chemotherapy for prostate cancer in the last 2 years.My scans show cancer has spread to my bones or other areas.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan Treatment
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being accepted into the experiment?
"Affirmative. According to data published on clinicaltrials.gov, this medical trial is currently recruiting patients. It was initially posted in October 24th 2018 and last updated on the 28th of October 2022. The research team are looking for 55 individuals across 3 different locations."
Answered by AI
Does this experimental trial introduce any innovative approaches?
"At the moment, 33 studies concerning IMMU-132 are active across 418 cities and 32 nations. The first ever trial was held in 2018 by Hoffmann-La Roche with 435 participants, and it has successfully concluded Phase 1 & 2 of drug approval. Additionally, two additional trials have been conducted since then."
Answered by AI
What clinical conditions has IMMU-132 been demonstrated to ameliorate?
"IMMU-132 is an efficacious treatment for therapeutic procedures, pharmacotherapy, and uc 84572."
Answered by AI
Is it feasible to administer IMMU-132 without posing a risk to patient safety?
"IMMU-132 has been given a rating of 2 on the safety scale, since its Phase 2 designation means that while it may be safe, there is no evidence yet to support clinical efficacy."
Answered by AI
Is there any capacity left for this research trial?
"Indeed, the clinicaltrials.gov website specifies that this trial is currently enrolling participants. Published on October 24 2018 and most recently updated on October 28 2022, 55 patients are needed from 3 distinct medical locations."
Answered by AI
Are there analogous experiments on IMMU-132 in the literature?
"Presently, 33 clinical trials are examining the efficacy of IMMU-132. Of those in operation, 5 have reached Phase 3. Locations for these studies span from Birmingham to Victoria and number 1397 sites in total."
Answered by AI
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