21 Participants Needed

Combination Therapy for Metastatic Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer.

Do I need to stop taking my current medications to join the trial?

The trial requires a washout period (time without taking certain medications) for specific drugs. If you are taking strong or moderate CYP3A inducers or inhibitors, you will need to stop them for a certain period before starting olaparib. The washout period is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other inducers, and 2 weeks for inhibitors.

Is the combination therapy for metastatic prostate cancer safe for humans?

Abiraterone acetate (Zytiga) combined with prednisone has been shown to have an acceptable and manageable safety profile in clinical trials for metastatic castration-resistant prostate cancer. It is generally well-tolerated, with safety data supporting its use in patients who have or have not received chemotherapy.12345

What makes the combination therapy for metastatic prostate cancer unique?

This treatment is unique because it combines multiple therapies, including abiraterone, which is an oral drug that blocks hormone production, with prednisone, ADT, radiotherapy, and olaparib, offering a comprehensive approach to improve survival and quality of life in patients with metastatic prostate cancer.13678

What data supports the effectiveness of the drug combination therapy for metastatic prostate cancer?

Research shows that adding abiraterone acetate with prednisone to androgen deprivation therapy (ADT) significantly improves survival and quality of life for patients with metastatic prostate cancer. This combination has been effective in both hormone-sensitive and castration-resistant forms of the disease, indicating its broad applicability in improving patient outcomes.6891011

Who Is on the Research Team?

Dr. Zachery R. Reichert, MD | Ann Arbor ...

Zachery R. Reichert

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion 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.
See 11 more

Exclusion Criteria

Life expectancy ≤3 years in view of treating provider
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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal radiation with pulsed systemic therapy of Abiraterone, ADT, and Lynparza

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for long-term outcomes and adverse events

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone
  • Androgen Deprivation Therapy (ADT)
  • External Beam Radiotherapy
  • Olaparib
  • Prednisone
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Abiraterone, ADT, Radiation and OlaparibExperimental Treatment5 Interventions

Abiraterone is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Zytiga for:
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Approved in European Union as Zytiga for:
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Approved in Canada as Zytiga for:
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Approved in Japan as Zytiga for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Published Research Related to This Trial

Abiraterone acetate combined with prednisone significantly improves overall survival (34.7 months vs 30.3 months) and radiologic progression-free survival (16.5 months vs 8.3 months) in patients with metastatic castration-resistant prostate cancer compared to placebo.
The treatment is generally well-tolerated, with manageable side effects primarily related to mineral corticoid excess, and it also enhances the perceived quality of life for patients.
[Abiraterone in castration resistant prostate cancer.]Juárez Soto, A., Caballero Cobos, R., Campanario Pérez, R., et al.[2018]
Adding abiraterone acetate plus prednisone/prednisolone (AAP) to androgen deprivation therapy (ADT) significantly reduces the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) by 38%, translating to a 14% absolute improvement in overall survival over three years, based on data from two major trials involving 82% of participants.
The addition of AAP also leads to a 55% reduction in the risk of clinical or radiological progression-free survival, with a 28% absolute improvement at three years, although there is an increased risk of certain grade III-IV toxicities, particularly cardiac and hepatic, without an increase in overall mortality.
Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis.Rydzewska, LHM., Burdett, S., Vale, CL., et al.[2023]
In a real-world study involving 1108 patients with metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate plus prednisone (AAP) was found to be effective as both first-line and second-line treatment, with median overall survival of 27.1 months for first-line and 23.4 months for second-line therapy.
The treatment was well tolerated across all patient subgroups, including those with cardiovascular comorbidities, and no unexpected adverse events were reported, indicating a favorable safety profile.
Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.Bjartell, A., Lumen, N., Maroto, P., et al.[2021]

Citations

[Abiraterone in castration resistant prostate cancer.] [2018]
Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis. [2023]
Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. [2021]
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. [2022]
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. [2023]
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Abiraterone Acetate: A Review in Metastatic Castration-Resistant Prostrate Cancer. [2019]
Value of treatment in clinical trials versus the real world: the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden. [2017]
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]
Current advances in intratumoral androgen metabolism in castration-resistant prostate cancer. [2018]
Practical guide to the use of abiraterone in castration resistant prostate cancer. [2023]
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