← Back to Search

Antiandrogen

Rucaparib + Enzalutamide for Prostate Cancer (CASPAR Trial)

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Measurable or non-measurable metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

CASPAR Trial Summary

This trial is testing if a combination of two drugs, rucaparib and enzalutamide, is better than enzalutamide alone for treating men with prostate cancer that has spread and become resistant to testosterone-deprivation therapy.

Who is the study for?
Men with metastatic prostate cancer resistant to testosterone-deprivation therapy are eligible. They must have documented prostate adenocarcinoma, radiographic progression, and no central nervous system metastases that aren't stable or treated. Participants need to be off certain drugs affecting liver enzymes and recovered from major surgeries or treatments. No prior treatment for metastatic castration-resistant prostate cancer is allowed.Check my eligibility
What is being tested?
The trial tests if adding Rucaparib (a PARP inhibitor) to Enzalutamide improves outcomes in men whose prostate cancer has spread and resists hormone therapy. It's a phase III study where patients are randomly assigned either the combination of both drugs or Enzalutamide alone, plus placebos as needed.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, potential heart issues like arrhythmias or angina, seizures for those at risk, and other common drug-related reactions.

CASPAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have available tissue samples from my cancer for testing.
Select...
My cancer has spread and can be measured or not.
Select...
I do not have any active infections needing treatment right now.
Select...
I am able to care for myself and perform daily activities.
Select...
I haven't had serious heart issues or strokes in the last 3 months.
Select...
My current medications are monitored for interactions by my doctor.
Select...
My liver functions well and I don't have severe liver disease.
Select...
I am not taking strong medication that affects certain liver enzymes.
Select...
I haven't had seizures or conditions increasing seizure risk in the last 2 years.
Select...
My PSA levels have been rising, showing my prostate cancer is progressing.
Select...
I am not allergic to enzalutamide, rucaparib, or their ingredients.
Select...
I do not have untreated spinal issues related to cancer.
Select...
I haven't received blood products or certain blood cell growth factors in the last 14 days.
Select...
My prostate cancer has spread to my bones and is getting worse.
Select...
I don't have plans for treatments specifically for bone pain relief.
Select...
I don't have a history of long-term low blood counts without a known cause.
Select...
I have stopped all cancer treatments except for hormone therapy and bone treatments, and have recovered from side effects.
Select...
It's been over 4 weeks or 5 half-lives since my last experimental treatment.
Select...
It has been over 4 weeks since my last major surgery or radiation treatment.
Select...
I do not have any stomach or bowel problems affecting medication absorption.
Select...
I don't currently have, nor have I recently had, worsening brain metastases.
Select...
I have not received any treatment for prostate cancer that has spread and is resistant to hormonal therapy.
Select...
It's been over 2 weeks since my last cancer-related medication.
Select...
My prostate cancer has been confirmed by lab tests.
Select...
I have used docetaxel or anti-androgens for non-metastatic or early-stage metastatic prostate cancer.
Select...
I haven't been treated for another cancer within the last 2 years, except for non-dangerous skin cancers.
Select...
My cancer has worsened despite hormone therapy or after surgical removal of testicles.
Select...
I have not been treated with enzalutamide, rucaparib, any PARP inhibitor, or platinum chemotherapy.

CASPAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Radiographic progression-free survival (rPFS)
Secondary outcome measures
Best response by serum prostate specific antigen (PSA)
Therapeutic procedure
Duration of overall response
+7 more
Other outcome measures
Laboratory correlative science
Quality of life

CASPAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (enzalutamide, rucaparib)Experimental Treatment7 Interventions
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.
Group II: Arm II (enzalutamide, placebo)Active Control6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Rucaparib camsylate
2018
Completed Phase 1
~20
Degarelix
2002
Completed Phase 3
~3600
Leuprolide Acetate
2002
Completed Phase 3
~1890
Goserelin Acetate
2007
Completed Phase 3
~1040

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,573 Total Patients Enrolled
30 Trials studying Prostate Cancer
5,924 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,585 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Arpit Rao, MDStudy ChairBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Rucaparib camsylate a safe prescription medication?

"3."

Answered by AI

In how many different medical facilities is this research project being conducted currently?

"There are 100 patients enrolling in this clinical trial at the West Michigan Cancer Center in Kalamazoo, Saint Joseph Mercy Brighton in Brighton, and Spectrum Health at Butterworth Campus in Grand Rapids. There are also 100 other enrollees spread out across different locations."

Answered by AI

What is the main therapeutic purpose of Rucaparib camsylate?

"While Rucaparib camsylate is most frequently used to treat breast cancer, it can also help patients manage side effects of radiation therapy and endometrial thinning. It is even effective against stage t2b carcinoma of the prostate."

Answered by AI

Can patients sign up for this clinical trial at this time?

"That is correct, based on the information available clinicaltrials.gov this study is looking for 1002 patients at 100 different locations and is still actively recruiting as of 9/25/2022."

Answered by AI

How many people have been signed up to participate in this clinical trial?

"That is accurate, the clinicaltrials.gov website shows that this trial is open and looking for candidates. The listing appeared on 2/19/2021 and was updated as recently as 9/25/2022. They are hoping to 1002 people across 100 different locations."

Answered by AI

Have other similar trials been conducted in the past?

"Rucaparib camsylate has been researched since 2000 when it was first trialed by AstraZeneca. The Phase 3 drug approval happened in light of the successful 600 person study. Today, there are 245 active studies involving Rucaparib camsylate being conducted across 63 countries and 2316 cities"

Answered by AI

What goals does this research aim to achieve?

"The aim of this study, which will be conducted over a period of up to 5 years after treatment, is to assess overall survival rates. Secondary outcomes include the incidence of adverse events as measured by the National Cancer Institute's Common Toxicity Criteria, prostate specific antigen (PSA) response rates, and radiographic progression-free survival within HRRm status. Treatment arm comparisons will be made using chi-square tests and log-rank tests, with median times per treatment arm being reported."

Answered by AI

What similar investigations has Rucaparib camsylate been a part of in the past?

"Rucaparib camsylate is being studied in 245 different clinical trials. Of those, 71 are Phase 3 trials. Many of the studies related to Rucaparib camsylate originate from Lincoln, Nebraska; however, there are 14809 total locations running these medical trials."

Answered by AI
~2 spots leftby May 2024