Study Summary
This trial is studying androgen ablation therapy with or without niraparib after radiation therapy in treating patients with prostate cancer.
Eligible Conditions
- Prostate Cancer
- Stage III Prostate Cancer
- Stage II Prostate Cancer
- Stage IIIA Prostate Cancer
- Stage IIIB Prostate Cancer
- Stage IVA Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: Up to 3 years
Year 3
Overall survival
Year 3
Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)
Year 3
Eugonadal progression-free survival
Progression-free survival
Up to 3 years
Incidence and severity of adverse events (AEs)
Incidence and severity of serious adverse events (SAEs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Group A (Apa, ADT, XRT)
1 of 2
Group B (Apa, ADT, XRT, AAP, niraparib)
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: Radiation Therapy · No Placebo Group · Phase 2
Group B (Apa, ADT, XRT, AAP, niraparib)Experimental Group · 7 Interventions: Biopsy, Niraparib, Apalutamide, Radiation Therapy, Antiandrogen Therapy, Abiraterone Acetate, Prednisone · Intervention Types: Procedure, Drug, Drug, Radiation, Drug, Drug, Drug
Group A (Apa, ADT, XRT)ActiveComparator Group · 4 Interventions: Biopsy, Apalutamide, Radiation Therapy, Antiandrogen Therapy · Intervention Types: Procedure, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1120
Niraparib
FDA approved
Apalutamide
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Antiandrogen Therapy
2015
Completed Phase 1
~10
Abiraterone
FDA approved
Cortisone
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,171 Total Patients Enrolled
89 Trials studying Prostate Cancer
27,335 Patients Enrolled for Prostate Cancer
Patrick G PiliePrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The Eastern Cooperative Oncology Group (ECOG) performance status of <= 2 means that a person is capable of light work.
Hemoglobin levels of 10.0 g/dL or greater within seven days of treatment registration are required.
Prostate cancer that is classified as high-risk or very high-risk because it meets at least one of the following criteria: a PSA level of 20 ng/mL or higher, evidence of prostate cancer that has spread to the lymph nodes (T3a or higher), or a Gleason score of 8 or higher.
The person is willing to go through medical castration in order to maintain testosterone levels of less than 50 ng/dL throughout systemic treatment or has undergone bilateral orchiectomy.
is mandatory
It is necessary to get consent from a participant before starting any study-related procedures.
Patients must agree to have tissue collected for correlative studies at the specified timepoints.
All men aged 18 or older are welcome.
therapies
The text is discussing a plan to treat prostate cancer
The patient's ANC must be 1.5x10^9/L or higher within 7 days of registration in order to be treated with this study drug.
You have histologically or cytologically confirmed prostate carcinoma.
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Conditions
Cancer Related
Treatments