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Copanlisib + Degarelix for Prostate Cancer

Phase 1 & 2

Waitlist Available

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

Must not have

Prior radiation to prostate

A diagnosis of diabetes (type 1 or 2) on medications for the purpose of treating hyperglycemia or HgbA1C > 7 will be excluded from study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment for my prostate.

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I do not have diabetes or my HgbA1C is 7 or lower.

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I don't have any other cancers needing treatment except for certain skin or superficial bladder cancers.

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My prostate cancer has spread beyond the pelvis, confirmed by scans.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3730

Copanlisib

2016

Completed Phase 2

~130