NCT04455750|Active Not RecruitingPhase 3DMCFDA Drug

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

CASPAR

CASPAR - A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-Line Metastatic Castration-Resistant Prostate Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A031902NCI-2020-02360U10CA180821

Study Type

interventional

Target

Locations

1 country

Sites

414

Timeline

RegisteredJul 2020

StartedOct 2021

CompletionSep 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

16mo left

Started Oct 2021

Longer than P75 for phase_3

Geographic Reach

1 country

414 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

Study Progress78%

Oct 2021Sep 2027

First Submitted

Initial submission to the registry

June 17, 2020

Completed

15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed

1.3 years until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

June 17, 2020

Last Update Submit

February 3, 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

Outcome Measures

Primary Outcomes (2)

Radiographic progression-free survival (rPFS)
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.
Up to 5 years post treatment
Overall survival (OS)
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.
Up to 5 years post treatment

Secondary Outcomes (10)

Radiographic progression-free survival (rPFS) within HRRm status
Up to 5 years post treatment
Time to unequivocal clinical progression
Up to 5 years post treatment
Overall survival by HRRm status
Up to 5 years post treatment
Overall response rate
Up to 1 year after completion of treatment
Duration of overall response
Up to 1 year after completion of treatment
+5 more secondary outcomes

Other Outcomes (4)

Quality of life
12 months
Quality of life
12 months
Laboratory correlative science
Up to 1 year after completion of treatment
+1 more other outcomes

Study Arms (2)

Arm I (enzalutamide, rucaparib)

EXPERIMENTAL

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.

Drug: EnzalutamideDrug: Rucaparib camsylateDrug: Leuprolide AcetateDrug: Goserelin AcetateDrug: DegarelixOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (enzalutamide, placebo)

ACTIVE COMPARATOR

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.

Drug: EnzalutamideDrug: PlaceboDrug: Leuprolide AcetateDrug: Goserelin AcetateOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

EnzalutamideDRUG

Given PO

Arm I (enzalutamide, rucaparib)Arm II (enzalutamide, placebo)

PlaceboDRUG

Given PO

Arm II (enzalutamide, placebo)

Leuprolide AcetateDRUG

Given IM

Arm I (enzalutamide, rucaparib)Arm II (enzalutamide, placebo)

Goserelin AcetateDRUG

Given SC

Arm I (enzalutamide, rucaparib)Arm II (enzalutamide, placebo)

DegarelixDRUG

Given SC

Arm I (enzalutamide, rucaparib)

Quality-of-Life AssessmentOTHER

Ancillary studies

Arm I (enzalutamide, rucaparib)Arm II (enzalutamide, placebo)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (enzalutamide, rucaparib)Arm II (enzalutamide, placebo)

Rucaparib camsylateDRUG

Given PO

Arm I (enzalutamide, rucaparib)

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (414)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC