Trial · Interventional
Active, not recruitingPhase 3Registry dataA Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
Short name CASPAR
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 61 participants (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 14 Oct 2021
- Primary completion
- 15 Mar 2027 (estimated)
- Completion
- Sept 2027 (estimated)
- First posted
- 2 Jul 2020
- Last update posted
- 5 Feb 2026
- Conditions
- Castration-Resistant Prostate Carcinoma · Metastatic Prostate Adenocarcinoma · Stage IV Prostate Cancer AJCC v8 · Stage IVA Prostate Cancer AJCC v8 · Stage IVB Prostate Cancer AJCC v8
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- EnzalutamideDrug
- Rucaparib camsylateDrug
- PlaceboDrug
- Leuprolide AcetateDrug
- Goserelin AcetateDrug
- DegarelixDrug
- Quality-of-Life AssessmentOther
- Questionnaire AdministrationOther
Arms2
Experimental
Arm I (enzalutamide, rucaparib)
Patients receive enzalutamide PO QD and rucaparib PO BID. Patients who did not undergo bilateral orchiectomy also receive ADT consisting of leuprolide acetate IM, goserelin acetate SC every 12 weeks or degarelix SC. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Active comparator
Arm II (enzalutamide, placebo)
Patients receive enzalutamide PO QD and placebo PO BID. Patients who did not undergo bilateral orchiectomy also receive ADT consisting of leuprolide acetate IM, goserelin acetate SC every 12 weeks or degarelix SC. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary outcomes2
Outcomes the sponsor listed as primary.
Radiographic progression-free survival (rPFS)
Time frame · Up to 5 years post treatment
Registry description
Radiographic progression-free survival (rPFS) is defined as the time from randomization to date of disease progression or death due to any cause. rPFS time will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Overall survival (OS)
Time frame · Up to 5 years post treatment
Registry description
Overall survival is defined as the time from randomization to death due to any cause. Overall survival time will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Secondary outcomes(10)
Radiographic progression-free survival (rPFS) within HRRm status
Time frame · Up to 5 years post treatment
Registry description
Defined as the time from randomization to date of disease progression or death due to any cause. rPFS time will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Time to unequivocal clinical progression
Time frame · Up to 5 years post treatment
Registry description
Defined as deterioration in clinical status clearly attributable to prostate cancer progression with occurrence of cancer pain requiring initiation of chronic administration of opiate analgesia, or an immediate need to re-initiate cytotoxic chemotherapy, radiation therapy or surgical intervention for disease-progression related events; or deterioration of Eastern Cooperative Oncology Group (ECOG) performance status to 3 or greater. Time to unequivocal clinical progression will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Overall survival by HRRm status
Time frame · Up to 5 years post treatment
Registry description
Defined as the time from randomization to death due to any cause.Overall survival time will be compared between the treatment arms using a stratified (by HRRm status) log-rank test. Median times per treatment arms/HRRm status will be reported.
Overall response rate
Time frame · Up to 1 year after completion of treatment
Registry description
Defined as confirmed radiographic complete response or partial response. The proportion of patients with confirmed radiographic response or partial response will be compared between the treatment arms with a chi-square test (or Fisher's exact test if more appropriate).
Duration of overall response
Time frame · Up to 1 year after completion of treatment
Registry description
Defined as the time from documentation of a radiographic response to disease progression. Duration of response time will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Prostate specific antigen (PSA) response rate
Time frame · Up to 1 year after completion of treatment
Registry description
Defined as \>= 50% reduction in PSA from baseline. The proportion of patients with PSA response will be compared between the treatment arms with a chi-square test (or Fisher's exact test if more appropriate).
Best response by serum prostate specific antigen (PSA)
Time frame · At 7 and 13 months from the start of treatment
Registry description
Defined as best percentage PSA decline from baseline to 7 and 13 months. The percent PSA decline will be compared between treatment arms with a Wilcoxon rank sum test.
Time to first symptomatic skeletal event (SSE)
Time frame · Up to 5 years after completion of treatment
Registry description
Defined as the time to first use of external-beam radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or nonvertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention. Time to first SSE will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Incidence of adverse events
Time frame · Up to 1 year after completion of treatment
Registry description
Frequency as measured by National Cancer Institute (NCI) Common Toxicity Criteria. The proportion of patients experiencing at least one grade 3+ adverse event will be compared between the treatment arms with a chi-square test (or Fisher's exact test if more appropriate).
Discontinuation for treatment emergent toxicities
Time frame · Up to 1 year after completion of treatment
Registry description
The proportion of patients who discontinued treatment for emergent toxicities will be compared between the treatment arms with a chi-square test (or Fisher's exact test if more appropriate).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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