102 Participants Needed

Combination Therapy for Prostate Cancer

(ASCLEPIuS Trial)

Recruiting at 5 trial locations
UC
Overseen ByUM Cancer AnswerLine
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new combination treatment for prostate cancer. It includes a cancer drug, precise radiation, and three other medications. The goal is to find the best dose and see if it can prevent cancer from coming back over time. Docetaxel is currently the standard treatment for hormone-refractory prostate cancer.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. Specifically, you must stop taking non-steroidal anti-androgens, steroidal antiandrogens, oral ketoconazole, chemotherapy, immunotherapy, estrogens, and radiopharmaceuticals 3 months before joining the study. Additionally, spironolactone and other investigational drug therapies are prohibited 30 days before starting the study treatment.

Is the combination therapy for prostate cancer safe for humans?

Stereotactic body radiation therapy (SBRT) for prostate cancer is generally considered safe, with studies indicating it does not cause major side effects and maintains quality of life.12345

How is the combination treatment for prostate cancer unique?

This combination treatment is unique because it combines multiple approaches: Abiraterone Acetate, which blocks a key enzyme to reduce hormone levels that fuel cancer growth; Leuprolide, which lowers testosterone levels; Niraparib, a PARP inhibitor that helps prevent cancer cells from repairing themselves; and Stereotactic Body Radiotherapy (SBRT), a precise form of radiation therapy. This multi-faceted approach targets prostate cancer from different angles, potentially improving outcomes compared to single treatments.36789

What data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for prostate cancer?

Research shows that Stereotactic Body Radiotherapy (SBRT) is effective for treating both localized and metastatic prostate cancer, with evidence suggesting it may enhance the immune response and work well in combination with other therapies.123710

Who Is on the Research Team?

WJ

William Jackson, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

DS

Daniel Spratt, M.D.

Principal Investigator

Case Western Reserve University - Seidman Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Men over 18 with advanced prostate cancer, who haven't had prior treatments like radiation or anti-androgen therapy. They must have a specific grade of cancer severity, adequate organ function, and agree to use effective contraception. Exclusions include those with other recent cancers, certain heart conditions, uncontrolled diabetes or hypertension, large prostate size (>80 cc), and allergies to the trial drugs.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent
My organs and bone marrow are working well.
My prostate cancer was confirmed through a biopsy.
See 12 more

Exclusion Criteria

Lack of tissue from biopsy to be sent for correlative studies
My doctor has noted a significant enlargement of my prostate's median lobe.
I do not have severe heart or blood vessel problems.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone

16 weeks

Treatment

Participants receive niraparib, abiraterone, leuprolide, prednisone, and SBRT

24 weeks
Regular visits for monitoring and treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone Acetate
  • Leuprolide
  • Niraparib
  • Stereotactic Body Radiotherapy (SBRT)
Trial Overview The study is testing the highest dose of niraparib (a PARP inhibitor) that's safe when combined with SBRT (targeted radiotherapy), abiraterone (hormone therapy), leuprolide (hormone therapy), and prednisone in men with prostate cancer. It also aims to see how well this combination prevents cancer from returning within three years.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Niraparid Dose EscalationExperimental Treatment4 Interventions

Abiraterone Acetate 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+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials
165
Recruited
579,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.
The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.
Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy.Ponti, E., Lancia, A., Ost, P., et al.[2022]
In a phase I/II clinical trial involving 91 prostate cancer patients, stereotactic body radiation therapy (SBRT) demonstrated excellent long-term efficacy, with a 98.6% freedom from biochemical failure at 5 years and 100% distant metastasis-free survival.
While SBRT was effective, higher doses (greater than 47.5 Gy) were associated with increased severe late toxicity, highlighting the need for careful dose management to minimize adverse effects.
Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial.Hannan, R., Tumati, V., Xie, XJ., et al.[2022]
Stereotactic body radiotherapy (SBRT) is effective for treating localized and metastatic prostate cancer, as prostate cancer shows increased sensitivity to higher radiation doses due to its low α/β ratio.
There is potential for combining SBRT with systemic therapies like androgen deprivation therapy (ADT) and immunotherapy, as SBRT may enhance immune responses, making it a promising area for ongoing research.
Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer.Adorno Febles, VR., Blacksburg, S., Haas, JA., et al.[2020]

Citations

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. [2022]
Stereotactic body radiation therapy for low and intermediate risk prostate cancer-Results from a multi-institutional clinical trial. [2022]
Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer. [2020]
Stereotactic body radiation therapy in the treatment of oligometastatic prostate cancer. [2022]
Stereotactic Body Radiotherapy for High-Risk Localized Carcinoma of the Prostate (SHARP) Consortium: Analysis of 344 Prospectively Treated Patients. [2022]
Stereotactic body radiotherapy as treatment for organ confined low- and intermediate-risk prostate carcinoma, a 7-year study. [2022]
Benefits of Using Stereotactic Body Radiotherapy in Patients With Metachronous Oligometastases of Hormone-Sensitive Prostate Cancer Detected by [18F]fluoromethylcholine PET/CT. [2022]
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Current advances in intratumoral androgen metabolism in castration-resistant prostate cancer. [2018]
Patient-Reported Financial Burden Following Stereotactic Body Radiation Therapy for Localized Prostate Cancer. [2022]
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