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Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer

ConditionsProstate CarcinomaStage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Completion of informed consent prior to any study specific procedures. Consent may be done remotely.

Patients must agree to tissue collection for correlative studies at the specified timepoints

Male aged 18 years and above

Histologically or cytologically confirmed prostate carcinoma

Disqualifiers

Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy

Patients who have prostate cancer with distant metastatic disease

Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer

Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥ 2) from previous anti-cancer therapies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abiraterone Acetate

    Drug

    Given PO

  • Antiandrogen Therapy

    Drug

    Given ADT

  • Apalutamide

    Drug

    Given PO

  • Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Niraparib

    Drug

    Given PO

  • Prednisone

    Drug

    Given PO

  • Radiation Therapy

    Radiation

    Undergo radiation therapy

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Group A (Apa, ADT, XRT)Active comparator 4 interventions
Group B: Group B (Apa, ADT, XRT, AAP, niraparib)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Composite radiographic progression-free survival(rPFS) and biochemical (PSA) progression-free survival (PFS)

Time frame
From randomization until progression, death, or last assessment without progression, whichever comes first, assessed at 3 years

Secondary outcomes

1

Incidence and severity of adverse events (AEs)

Adverse events will be recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 along with date and attribution to study treatment.

Time frame
Up to 3 years
2

Incidence and severity of serious adverse events (SAEs)

Graded by NCI CTCAE version 5.0.

Time frame
Up to 3 years
3

Overall survival

Time frame
From randomization until death or last contact, whichever comes first, assessed up to 3 years
4

Eugonadal progression-free survival

Assessed as composite radiographic PFS (rPFS) and biochemical (prostate specific antigen \[PSA\]) PFS among patients with non-castrate level testosterone. Eugonadal is defined as non-castrate levels of testosterone (\> 50 ng/mL).

Time frame
From randomization until progression, death, or last assessment without progression, whichever comes first, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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