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Copanlisib in Combination With Degarelix for Prostate Cancer

Q: Are individuals still eligible to participate in this ongoing research?

Indeed, the information provided on clinicaltrials.gov confirms that this trial is currently seeking participants. The original posting date for the clinical trial was January 11th, 2024 and it was last updated on the same day. The study aims to recruit a total of 37 individuals from seven designated sites.

Q: What is the overall participant count in this clinical study?

Indeed, the information available on clinicaltrials.gov indicates that this study is actively enrolling participants. The trial's initial posting was on January 11th, 2024, and it has been recently updated on the same date. A total of 37 patients will be admitted to the trial across seven different sites.

Q: Are multiple medical facilities in North America involved in conducting this clinical study?

For the purpose of this research, there are a total of 7 functioning medical facilities. These include Memorial Sloan Kettering Bergen (Limited Protocol Activities) situated in Montvale, Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) located in Basking Ridge, and Memorial Sloan Kettering <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Suffolk - Commack (Limited Protocol Activities) found in Commack. Additionally, there are an additional 4 sites available for participation in this study.

Phase 1 & 2

Recruiting

Led By Dana Rathkopf, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix A: Performance Status Criteria)

Histological or cytological evidence of prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is studying whether combining copanlisib and degarelix, given before surgery, is a safe and effective treatment for localized high-risk prostate cancer with minimal side effects.

Who is the study for?

This trial is for individuals with localized high-risk prostate cancer. Participants should be candidates for standard surgical treatment (radical prostatectomy). Specific inclusion and exclusion criteria are not provided, but typically these would involve health status, previous treatments, and other medical conditions.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of combining copanlisib with degarelix before surgery to remove the prostate. The goal is to see if this combination can help treat prostate cancer with minimal side effects.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for similar treatments include fatigue, nausea, skin reactions at injection sites, liver enzyme changes, blood sugar levels alterations and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My prostate cancer diagnosis was confirmed through lab tests.

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My prostate cancer is high-risk based on PSA levels, Gleason score, or its stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 2 determine the rate of pCR or MRD at Radical Prostatectomy

phase Ib determine the recommended phase 2 dose (RP2D) of copanlisib in combination with degarelix

Trial Design

1Treatment groups

Experimental Treatment

Group I: Copanlisib in Combination With DegarelixExperimental Treatment3 Interventions

Phase 1b: The starting Dose level 1 will be 45 mg with the intent of dose escalating to the standard dose of 60 mg approved for heme malignancy. In the event of > =2 DLT at Dose level 1 (45 mg) the study will be terminated. If >= 2 DLT in patients at Dose level 2 (60 mg), Dose level 1 (45 mg) will be the RP2D if <= 1 DLT out of 6 patients at this dose. Phase 2: Patients may dose reduce at the discretion of the investigator to the lowest dose of 45 mg. Participants who do not tolerate the copanlisib dose of 45 mg must discontinue study treatment permanently.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Degarelix

2002

Completed Phase 3

~3600

Copanlisib

2016

Completed Phase 2

~130

Radical Prostatectomy

2005

Completed Phase 2

~4550

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,861 Total Patients Enrolled

132 Trials studying Prostate Cancer

52,045 Patients Enrolled for Prostate Cancer

Dana Rathkopf, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

5 Previous Clinical Trials

127 Total Patients Enrolled

3 Trials studying Prostate Cancer

90 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Are individuals still eligible to participate in this ongoing research?

"Indeed, the information provided on clinicaltrials.gov confirms that this trial is currently seeking participants. The original posting date for the clinical trial was January 11th, 2024 and it was last updated on the same day. The study aims to recruit a total of 37 individuals from seven designated sites."

Answered by AI

What is the overall participant count in this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively enrolling participants. The trial's initial posting was on January 11th, 2024, and it has been recently updated on the same date. A total of 37 patients will be admitted to the trial across seven different sites."

Answered by AI

Are multiple medical facilities in North America involved in conducting this clinical study?

"For the purpose of this research, there are a total of 7 functioning medical facilities. These include Memorial Sloan Kettering Bergen (Limited Protocol Activities) situated in Montvale, Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) located in Basking Ridge, and Memorial Sloan Kettering Cancer Suffolk - Commack (Limited Protocol Activities) found in Commack. Additionally, there are an additional 4 sites available for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer

2024. "A Study of Copanlisib in Combination With Degarelix in People With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218667.