MDPK67b in Patients With Prostate Cancer

Launched by MED DISCOVERY SA · Oct 11, 2022

Keywords

ClinConnect Summary

This clinical trial, called MDPK67b in Patients With Prostate Cancer, is exploring a new treatment to see how safe it is for men with prostate cancer. Researchers want to understand how well the treatment is tolerated by patients and to look at any changes in the prostate tumor tissue samples after treatment. They are currently recruiting men aged 18 and older who have untreated prostate cancer or those whose cancer is being watched closely but is showing signs of progression.

To be eligible for this study, participants should have a specific type of prostate cancer that has a Gleason score of 7 or higher and should be planning to undergo surgery about three weeks later. They should also be in generally good health, meaning their blood counts and organ functions meet certain criteria. Those who join the trial will receive the treatment and will be monitored closely to assess their experiences and any potential side effects. It's important to note that participants will need to agree to certain requirements, like not donating sperm during the study. This trial offers a chance to contribute to important research that could help improve future treatments for prostate cancer.

Gender

MALE

Eligibility criteria

• • Subject screening criteria
• • 1. Patients aged 18 years or older.
• • 2. Patients who have untreated suspected PCa or PCa under active surveillance (AS) with progression/upgrading.
• • 3. Patients who signed a written screening phase ICF.
• • Subject non-screening criteria
• • 1. Patients who have an uncontrolled disease that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the Investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, diseases of the coagulation system, unstable or uncompensated cardiac, hepatic, renal, respiratory, or psychiatric disease.
• • 2. Patients who required a significant change in their concomitant medications during the week prior to screening visit, or who will likely need to have a change in their concomitant medications during the study. This includes any medication other than those required for PCa diagnosis or for RPE.
• • 3. Patients who have received prior radiotherapy to the prostate.
• • 4. Patients who have had prior exposure to MDPK67b.
• • 5. Patients who have participated in another clinical trial within 3 months prior to screening visit, except if in the opinion of the investigator the type of trial does not interfere in any way with the present trial (eg. non-interventional observational trial). In case of doubt, the sponsor's prior approval must be obtained and the decision to include such a patient will be documented in detail.
• • Non-screening criteria are exclusion criteria for the screening phase.
• • For the patients not participating in the screening phase (ie patients with previously established PCa diagnosis), all the criteria above shall be checked prior to enrolment in the treatment phase. However, these patients do not have to sign a screening ICF (screening criterion n°3 is not applicable), and for non-screening criterion n°5, the 3-month wash-out period is prior to the inclusion visit in the treatment phase.
• • Subject inclusion criteria
• • 1. Patients who still meet all the eligibility criteria checked at screening visit.
• • 2. Patients who have untreated PCa with a Gleason score of 7 (preferably) or higher, with local disease or with metastatic disease (if metastatic, no visceral metastases, no more than five bone or lymph node metastases), and are scheduled to undergo RPE about 3 weeks later.
• • 3. Patients with an expected minimal survival time of 12 months.
• 4. Patients who have an acceptable organ and marrow function as assessed at the inclusion visit and defined as follows:
• • 1. Absolute neutrophil count ≥ 1.5 × 109/L.
• • 2. Platelets ≥ 100 × 109/L.
• • 3. Hemoglobin ≥ 9 g/dL.
• • 4. Total bilirubin ≤ 1.5 × ULN, unless the patient has known Gilbert's syndrome.
• • 5. Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN in presence of liver metastasis.
• • 6. Serum creatinine ≤ 2.0 × ULN, or GFR ≥ 30 mL/min by Cockcroft-Gault.
• • 7. INR \<1.5, aPTT \< 60 s
• • 5. Patients with an ECOG performance status ≤ 1.
• • 6. Patients who agree to refrain to donate sperm for the duration of the study.
• • 7. Patients who signed a written treatment phase ICF.