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Hormone Therapy

Combination Therapy for Metastatic Prostate Cancer

Phase 2
Recruiting
Led By Zachery Reichert, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG ≤1
Histologic or cytologic diagnosis of prostate adenocarcinoma (pure small cell or pure neuroendocrine prostate cancer are not allowed)
Must not have
Clinically significant cardiovascular disease as evidenced by: myocardial infarction or arterial thrombotic events (e.g. stroke) in the past 6 months, resting EKG indicating uncontrolled, potentially reversible cardiac candiation, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, QTc Fridericia prolongation >500 ms) or patients with congenital long QT syndrome, severe or unstable angina, uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed) or other (non-atrial fibrillation) cardiac arrhythmia requiring therapy, Active New York Heart Association Class II-IV heart failure, if any prior history of CHF (regardless of New York Heart Association assignment), a cardiac ejection fraction measurement (by echocardiography or multigated acquisition scan) is required within 6 months and mush not be <50%, Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure, Prior revascularization procedure (coronary, carotid or peripheral artery stenosis) within the past 12 months, History of uncontrolled pituitary or adrenal dysfunction, Active infection or other medical condition that would make prednisone use contraindicated, Any chronic medical condition requiring a systemic dose of corticosteroid >10 mg prednisone daily, Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation, Participation in another clinical study with an investigational product or investigational medical devices within 1 month of registration, Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the University of Michigan), Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements, Uncontrolled hypertension (systolic blood pressure ≥160 mmHg) of diastolic blood pressure ≥95 mmHg. Patients with documented white coat syndrome (with home blood pressure machine compared to office for calibration) are allowed if home blood pressure measured daily for a week meet eligibility, Known hypersensitivity to olaparib, abiraterone, planned ADT agent (e.g. leuprolide, goserelin, degarelix), any of the excipients of any of these agents (olaparib, abiraterone, planned ADT agent) or drugs with a similar chemical structure to them or class to agents (olaparib, abiraterone or planned ADT), Immunocompromised patients, Patients who are considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples not discussed elsewhere include, but are not limited to uncontrolled seizure disorder, superior vena cava syndrome or any psychiatric disorder that prohibits informed consent, Persistent toxicities (CTCAE Grade ≥2) caused by previous cancer therapy, excluding alopecia or sensory peripheral neuropathy, Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Prior orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months months after enrollment
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new combination of treatments for men with castration sensitive prostate cancer that has spread to a limited number of sites. The goal is to see if this new combination is safe and effective.

Who is the study for?
Men with castration sensitive oligometastatic prostate cancer, who are medically fit for radiotherapy and have had prior prostate surgery or radiation. They must not have more than 5 metastatic sites suitable for radiation, no brain metastases, and an ECOG performance status of ≤1. Participants need normal organ function, a rising PSA level post-treatment, and agree to use contraception.
What is being tested?
The trial is testing the combination of focal radiation therapy with systemic hormone therapy (ADT) and chemotherapy drugs Abiraterone and Olaparib in men with limited spread prostate cancer. It's a phase 2 study aiming to see if this treatment can effectively manage the disease.
What are the potential side effects?
Possible side effects include fatigue, digestive issues like nausea or diarrhea from chemotherapy; hot flashes from hormone therapy; skin irritation from radiation; potential blood disorders; liver function changes due to medication; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have been diagnosed with prostate cancer, but it's not small cell or neuroendocrine type.
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I have not had radiation outside of the prostate or pelvic area for my cancer.
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My PSA levels have risen after prostate surgery or radiotherapy.
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I have prostate cancer with 1 to 5 areas identified for radiation, not seen on FDG-PET.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to remove one or both of my testicles.
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I have been diagnosed with MDS, AML, or have symptoms that suggest these conditions.
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I have brain metastases but no symptoms.
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I have not had major surgery in the last 2 weeks or have fully recovered from it.
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I have severe liver problems.
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I do not have an active hepatitis infection.
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I have previously been treated with PARP inhibitors or certain chemotherapy drugs.
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I need urgent radiation due to symptoms of spinal cord compression.
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I am not currently using, or have stopped using certain strong or moderate drug inducers as required before starting Olaparib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients without treatment failure at 24 months
Secondary study objectives
Frequency of adverse events grade 3 or higher and attributable to study treatment
Percentage of patients with undetectable PSA, testosterone >150 ng/dL and without treatment failure.
Rate of obtaining an optimal PSA (PSA ≤ 0.2 ng/mL)
+2 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Dizziness
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abiraterone, ADT, Radiation and OlaparibExperimental Treatment5 Interventions
Abiraterone, ADT, radiation to all metastases and Olaparib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
Prednisone
FDA approved
External Beam Radiotherapy
1995
Completed Phase 3
~440
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~610
Olaparib
FDA approved

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,206 Total Patients Enrolled
28 Trials studying Prostate Cancer
3,031 Patients Enrolled for Prostate Cancer
Zachery Reichert, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
2 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Prostate Cancer
13 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04748042 — Phase 2
Prostate Cancer Research Study Groups: Abiraterone, ADT, Radiation and Olaparib
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT04748042 — Phase 2
Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748042 — Phase 2
~2 spots leftby May 2025
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