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

NCT ID: NCT06218667

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2027-01-31

Brief Summary

The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Copanlisib in Combination With Degarelix

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.

Group Type: EXPERIMENTAL

Copanlisib

Intervention Type: DRUG

Dose level 1 (starting dose): 45 mg of copanlisib IV weekly x 3 weeks on/1 week off Dose level 2 (standard dose): 60 mg of copanlisib IV weekly x 3 weeks on/1 week off

Degarelix

Intervention Type: DRUG

Degarelix (GnRH antagonist): 240 mg loading dose sub-cutaneous once on C1D1; 80 mg maintenance dose on C2D1 and C3D1.

Radical Prostatectomy

Intervention Type: PROCEDURE

Standard treatment

Interventions

Copanlisib

Dose level 1 (starting dose): 45 mg of copanlisib IV weekly x 3 weeks on/1 week off Dose level 2 (standard dose): 60 mg of copanlisib IV weekly x 3 weeks on/1 week off

Intervention Type: DRUG

Degarelix

Degarelix (GnRH antagonist): 240 mg loading dose sub-cutaneous once on C1D1; 80 mg maintenance dose on C2D1 and C3D1.

Intervention Type: DRUG

Radical Prostatectomy

Standard treatment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
• Individuals with prostate cancer 18 years of age and above
• Histological or cytological evidence of prostate cancer
• Documented high-risk localized prostate cancer based on one or more of the following NCCN criteria:

1. PSA >20ng/ml or

2. Gleason ≥8 or

3. Clinical stage ≥cT3a

• Known PTEN status:

1. PTEN loss by IHC for participants in the PTEN loss cohort

2. PTEN intact by IHC for participants in the exploratory PTEN intact cohort (only available if PTEN intact cohort is opened)

• Candidate for RP as determined by treating physician
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix A: Performance Status Criteria)
• Normal organ function with acceptable initial laboratory values within 28 days of registration:

• ANC ≥ 1.5 K/mcL
• Hemoglobin ≥ 9g/dL
• Platelet count ≤100 K/mcL
• Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
• Potassium within institutional normal range
• Total Bilirubin ≤ 1.5 x ULN (Note: In participants with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible)
• SGOT (AST) ≤ 2.5 x ULN
• SGPT (ALT) ≤ 2.5 x ULN
• GFR (MDRD) ≥ 30 mL/min/1.73 m^2
• Participants must agree to use a medically acceptable method of birth control (i.e., spermicide in conjunction with a barrier such as a condom) or sexual abstinence prior to registration, for the duration of study participation and for at least 5 months after the last treatment with copanlisib.

Exclusion Criteria

• Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan
• On ADT (GnRH agonists or antagonists) for > 4 weeks at time of consent
• Prior radiation to prostate
• Medical conditions such as uncontrolled hypertension or cardiac disease that would, in the opinion of the investigator preclude participation in this protocol
• A diagnosis of diabetes (type 1 or 2) on medications for the purpose of treating hyperglycemia or HgbA1C > 7 will be excluded from study
• Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for basal or squamous cell skin cancer or superficial bladder cancer that has previously been treated.
• Use of any prohibited concomitant medications including herbal supplements Medications With the Potential for Drug-Drug Interactions) within 2 weeks prior to treatment start
• Receiving any other investigational agents within 4 weeks or 5x the half-life of investigational agent (whichever is longer) from this study's treatment start
• Known allergy to any of the compounds under investigation
• Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Rathkopf, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

23-331

Identifier Type: -

Identifier Source: org_study_id