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Clinical Trials in Mexico / NCT04455750
Active, not recruiting Phase 3

A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy

NCT04455750 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2021-10-14
Last updated
2026-02-05

Condition(s) studied

Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IV Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8

Investigational drug(s) / intervention(s)

Enzalutamide →Rucaparib camsylatePlaceboLeuprolide Acetate →Goserelin Acetate →Degarelix →Quality-of-Life AssessmentQuestionnaire Administration

Enzalutamide: Given PO

Rucaparib camsylate: Given PO

Placebo: Given PO

Leuprolide Acetate: Given IM

Goserelin Acetate: Given SC

Degarelix: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Study summary

This randomized, placebo-controlled phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologic/cytologic documentation of prostate adenocarcinoma * Adequate archival tumor specimen or archival slides must be available to be tested as part of the trial screening (most recent metastatic site biopsy preferred, but primary prostate biopsy allowed if metastatic biopsy is not available or inadequate. A new biopsy is not required for pre-registration in the trial as long as sufficient archival tissue is available). Due to significant variability between tests, results from an existing targeted next-generation exome sequencing test may not be used for this trial * Progressive disease must be demonstrated at study entry while the patient is on continuous androgen deprivation therapy (ADT) or status post orchiectomy. Progressive disease is defined as one or more of the following criteria: * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 1.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy (\>=4 weeks since last flutamide, bicalutamide or nilutamide, apalutamide or darolutamide) * Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue lesions * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria * Measurable or non-measurable metastatic disease * No prior therapy for metastatic castration-resistant prostate cancer, defined as a treatment given for prostate cancer with radiographically-detectable metastasis and a serum testosterone level less than 50 ng/dl (1.73 nmol/L) at the time of registration * \>= 2 weeks or 5 half-lives (whichever is shorter) since prior therapy with flutamide, dutasteride, bicalutamide, niltamide, finasteride, aminoglutethimide, estrogens, cytoproterone, chemotherapy, abiraterone, apalutamide, or darolutamide * \>= 4 weeks or 5 half-lives (whichever is shorter) since any prior investigational therapy * \>= 4 weeks since a major surgery or radiation * No prior therapy with enzalutamide, rucaparib or any other PARP inhibitor, or platinum chemotherapy * Prior docetaxel and/or novel anti-androgen use is allowed only if given in the hormone-sensitive non-metastatic or metastatic, or castration-resistant non-metastatic disease setting * Patient must have discontinued all previous treatments for cancer (except ADT and bone anti-responsive therapies such as denosumab or zoledronic acid) and must have recovered from all acute side effects of prior therapy or surgical procedures to =\< grade 1 or baseline prior to randomization, with the exception of fatigue, alopecia or peripheral neuropathy * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * Serum testosterone =\< 50 ng/dl (=\< 1.73 nmol/L) * Serum creatinine =\< 1.5 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transferase (ALT) =\< 2.5 x upper limit of normal (ULN) * No clinically suspected central nervous system (CNS) (leptomeningeal or parenchymal) metastases. Patients with a history of CNS metastasis(s) will be allowed as long (1) as the metastatic site(s) were adequately treated as demonstrated by clinical and radiographic improvement, AND (2) the patient has recovered from the intervention (no residual adverse events \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1), AND (3) the patient has remained without occurrence of new or worsening CNS symptoms for a period of 28 days prior to pre-registration * No known or suspected history of cytopenia (low white blood cell \[WBC\], hemoglobin or platelet count) of greater than 3 months duration with an unknown cause, myelodysplastic syndrome, or hematologic malignancies * No blood product transfusion, granulocyte/granulocyte-macrophage-colony stimulating factor (G-CSF/GM-CSF), or erythropoietin/thrombopoietin use within 14 days of pre-registration * No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, myocardial ischemia or infarction, severe or unstable angina, New York Heart Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months * No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma) within 2 years * No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction * No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of registration * No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery * No untreated spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression * No known or suspected contraindications or hypersensitivity to enzalutamide, rucaparib, or to any of the excipients * No known or suspected gastrointestinal disorder affecting absorption of oral medications * No prior malignancy for which the last treatment was given within the past 2 years, or any active concurrent malignancy with the exception of non-melanomatous localized skin cancers (such as squamous or basal cell carcinoma of the skin) * Any concomitant medications that are strong inhibitors of CYP2C8 or inducers of CYP3A4 cytochrome enzymes must be discontinued prior to registration. Dose adjustments per Food and Drug Administration (FDA) label or clinical judgement should be considered for any concomitant medications that are moderate inhibitors of CYP2C8 or inducers of CYP3A4 cytochrome enzymes * Any concomitant medications that are substrates of CYP3A4, CYP2C9 and CYP2C19 cytochrome enzymes should be monitored closely per clinical judgement of the treating physician

Primary outcome measure(s)

Trial sites (414)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Cancer Center at Saint Joseph's Phoenix Arizona
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Kaiser Permanente Dublin Dublin California
Kaiser Permanente-Fremont Fremont California
Kaiser Permanente-Fresno Fresno California
Kaiser Permanente-Modesto Modesto California
Kaiser Permanente-Oakland Oakland California
Kaiser Permanente-Richmond Richmond California
Kaiser Permanente-Roseville Roseville California
Kaiser Permanente Downtown Commons Sacramento California
Kaiser Permanente-South Sacramento Sacramento California
Sharp Memorial Hospital San Diego California
Kaiser Permanente-San Francisco San Francisco California
Kaiser Permanente-Santa Teresa-San Jose San Jose California
Kaiser Permanente San Leandro San Leandro California
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
Kaiser San Rafael-Gallinas San Rafael California
Kaiser Permanente Medical Center - Santa Clara Santa Clara California
Mission Hope Medical Oncology - Santa Maria Santa Maria California
Kaiser Permanente-Santa Rosa Santa Rosa California
Kaiser Permanente-South San Francisco South San Francisco California
Saint Helena Hospital St. Helena California
Kaiser Permanente-Stockton Stockton California
Northbay Cancer Center Vacaville California
Kaiser Permanente Medical Center-Vacaville Vacaville California
Kaiser Permanente-Vallejo Vallejo California
Kaiser Permanente-Walnut Creek Walnut Creek California
Penrose-Saint Francis Healthcare Colorado Springs Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado

+ 374 more sites — see the full list on the official registry below.

On this site

📄 Xtandi (enzalutamide) drug profile →

More Alliance for Clinical Trials in Oncology trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04455750 on ClinicalTrials.gov ↗ ← All trials in Mexico