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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after enrollment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I have been diagnosed with prostate cancer, but it's not small cell or neuroendocrine type.
Select...
I have not had radiation outside of the prostate or pelvic area for my cancer.
Select...
My PSA levels have risen after prostate surgery or radiotherapy.
Select...
I have prostate cancer with 1 to 5 areas identified for radiation, not seen on FDG-PET.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients without treatment failure at 24 months
Secondary outcome measures
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 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
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%
Aspartate aminotransferase increased
9%
Dizziness
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
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
~530
Olaparib
FDA approved
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,232 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,957 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organ and bone marrow functions are normal as tested within the last 28 days.I am fully active and can carry on all my pre-disease activities without restriction.I am a candidate for hormone therapy for my cancer, as advised by my oncologist.I have had hormone therapy for cancer, and my testosterone levels are now above 150 ng/dL.I have had surgery to remove one or both of my testicles.I have been diagnosed with MDS, AML, or have symptoms that suggest these conditions.I have brain metastases but no symptoms.I have not had major surgery in the last 2 weeks or have fully recovered from it.I am medically cleared for radiotherapy.I am able to understand and sign the consent form.I had surgery or radiation aimed at curing my prostate cancer.I have severe liver problems.I do not have an active hepatitis infection.My cancer can be safely targeted with radiation according to my doctor.I will use a condom during and 6 months after treatment when with a partner who can get pregnant.I haven't had cancer treatment in the last 3 years, except for certain skin, bladder, or head and neck cancers.I have previously been treated with PARP inhibitors or certain chemotherapy drugs.I have been diagnosed with prostate cancer, but it's not small cell or neuroendocrine type.I have not had radiation outside of the prostate or pelvic area for my cancer.My PSA levels have risen after prostate surgery or radiotherapy.I need urgent radiation due to symptoms of spinal cord compression.I have prostate cancer with 1 to 5 areas identified for radiation, not seen on FDG-PET.I am not currently using, or have stopped using certain strong or moderate drug inducers as required before starting Olaparib.I am not currently using strong or moderate CYP3A inhibitors, or I can stop them 2 weeks before starting olaparib.I have received hormone therapy for my cancer up to 4 weeks ago or have recovered testosterone levels after such treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Abiraterone, ADT, Radiation and Olaparib
Awards:
This trial has 3 awards, including:- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Are participants being actively recruited for this experiment at this time?
"This clinical trial is currently recruiting participants, as indicated on the clinicaltrials.gov website. The trial was first posted on May 28th, 2021 and was last updated on September 21st, 2022."
Answered by AI
How many enrollees are part of this research project?
"That is correct, the trial is ongoing and looking for 29 patients at a single site. The listing was created on 5/28/2021 and updated on 9/21/2022 according to clinicaltrials.gov"
Answered by AI
What are some of the possible dangers associated with Olaparib?
"Olaparib was given a score of 2 because, while there is some evidence backing its safety, this medication has not yet been proven effective."
Answered by AI
What is Olaparib's efficacy in treating conditions?
"Olaparib is most frequently used to manage ulcerative colitis, but it can also help patients with varicella-zoster virus acute retinal necrosis, brain, and iritis."
Answered by AI
What is the precedence of Olaparib research?
"566 trials are being conducted worldwide to study Olaparib; 125 of these are in Phase 3. Most studies for Olaparib are based out of Phoenix, Arizona, but there 26014 total locations running Olaparib trials."
Answered by AI
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