Status:
WITHDRAWN
A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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:
- PSA \>20ng/ml or
- Gleason ≥8 or
- Clinical stage ≥cT3a
- Known PTEN status:
- PTEN loss by IHC for participants in the PTEN loss cohort
- 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
- 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
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06218667
Start Date
January 11 2024
End Date
January 1 2027
Last Update
October 31 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.