Rucaparib camsylate for Prostate Cancer

Saint Joseph Mercy Hospital, Ann Arbor, MI
Prostate Cancer+4 More ConditionsRucaparib camsylate - Drug

Study 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.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Stage IVB Prostate Cancer
  • Stage IV Prostate Cancer
  • Stage IVA Prostate Cancer
  • Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Up to 5 years post treatment

12 months
Quality of life
Month 13
Best response by serum prostate specific antigen (PSA)
Year 1
Therapeutic procedure
Duration of overall response
Incidence of adverse events
Laboratory correlative science
Overall response rate
Prostate specific antigen (PSA) response rate
Year 5
Time to first symptomatic skeletal event (SSE)
Year 5
Overall survival (OS)
Overall survival by HRRm status
Radiographic progression-free survival (rPFS)
Radiographic progression-free survival (rPFS) within HRRm status
Time to unequivocal clinical progression

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Arm II (enzalutamide, placebo)
1 of 2
Arm I (enzalutamide, rucaparib)
1 of 2

Active Control

Experimental Treatment

1002 Total Participants · 2 Treatment Groups

Primary Treatment: Rucaparib camsylate · Has Placebo Group · Phase 3

Arm I (enzalutamide, rucaparib)Experimental Group · 7 Interventions: Enzalutamide, Rucaparib camsylate, Degarelix, Questionnaire Administration, Leuprolide Acetate, Goserelin Acetate, Quality-of-Life Assessment · Intervention Types: Drug, Drug, Drug, Other, Drug, Drug, Other
Arm II (enzalutamide, placebo)ActiveComparator Group · 6 Interventions: Enzalutamide, Questionnaire Administration, Placebo, Leuprolide Acetate, Goserelin Acetate, Quality-of-Life Assessment · Intervention Types: Drug, Other, Drug, Drug, Drug, Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post treatment

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
507 Previous Clinical Trials
217,638 Total Patients Enrolled
30 Trials studying Prostate Cancer
5,923 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,234,396 Total Patients Enrolled
544 Trials studying Prostate Cancer
503,656 Patients Enrolled for Prostate Cancer
Arpit Rao, MDStudy ChairBaylor College of Medicine

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received treatment with enzalutamide, rucaparib, or any other PARP inhibitor or platinum chemotherapy in the past.
You may have received docetaxel and/or new anti-androgen medication only if it was given for hormone-sensitive non-metastatic or metastatic, or castration-resistant non-metastatic disease.
You have not had a seizure or any condition that increases your risk of having one in the past two years, such as a significant brain injury or stroke.
You are not scheduled to undergo any procedures to relieve bone pain, such as radiation therapy or surgery.
You don't have any known allergies or reasons why you cannot take enzalutamide or rucaparib.
If you are taking any medications that are processed by certain enzymes in your body, your doctor will watch you carefully during the study.

Frequently Asked Questions

Is Rucaparib camsylate a safe prescription medication?

"3." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

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

Unverified Answer

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

"That is accurate, the 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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.