- Not Yet Recruiting
- Treatment
- Interventional
- Drug
- PHASE1/PHASE2
- Milton S. Hershey Medical Center
- 40 Years -
Study Purpose
This Phase I/II open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.
Intervention
Drug : INM176
Eligibility Requirements
Phase I Inclusion Criteria
Willingness and ability to give informed consent.
Agree to comply with all study procedures and attend all study visits to the best of their ability.
Male aged \>=40 years.
History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if they meet one or more of the below criteria:
4a. Subjects with treated prostate cancer are eligible. 4b. Subjects with localized prostate cancer in low-risk group who were not on treatment or declined any treatment are eligible.
4c. Subjects with localized prostate cancer in the favorable intermediate-risk group who declined any treatment are eligible.
Subjects must not be undergoing concurrent radiation therapy or androgen deprivation therapy (ADT) at the time of enrollment.
ECOG performance status 0-2. 7. Subjects must have normal liver and kidney function as defined below:
a) total bilirubin within normal institutional limits,
b) AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal,
c) Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
d) Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.0 x 109/L).
8. Subjects and their partners must agree to use two medically accepted methods of contraception and must agree to continue use these methods during the trial and for at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.
9. Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 must be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed if deemed safe and appropriate by the investigator, or if an alternative medication can be substituted.
10. Subjects currently taking herbal supplements containing AGN extract, such as Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin, must discontinue these or any other supplements containing these products 4 weeks prior to starting study drug.
* Phase II Inclusion Criteria
Willingness and ability to give informed consent.
Agree to comply with all study procedures and attend all study visits to the best of their ability.
Male aged \>=40 years.
Histologically confirmed adenocarcinoma of Prostate. Subjects with history of neuroendocrine or small cell prostate cancer must be excluded.
Any T stage, N0-1, M0, any Gleason grade.
Subjects with treated prostate cancer, either post-radical prostatectomy (RP) or post-radiation therapy (RT). Subjects who have local recurrence in the prostate after treatment but decline further intervention are also eligible.
OR Subjects with localized prostate cancer (no distant or nodal metastases) who have declined any treatment after discussion with their treating physician.
No distant metastases disease confirmed by imaging (CT or MRI and bone scan or prostate-specific PET scan such as PSMA PET scan or Axumin PET scan).
Blood PSA level rising over 2 consecutive tests within the past 6 months, at least one week apart.
Not currently receiving concurrent androgen deprivation therapy, and testosterone levels should be within a non-castrate range (normal or at least \>50 ng/dL).
ECOG performance status 0-2.
Subjects must have normal liver and kidney function as defined below:
1. total bilirubin within normal institutional limits,
2. AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal (ULN),
3. Creatinine within 1.5 ULN of institutional limits OR creatinine clearance \> 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal,
4. Adequate bone marrow function (Hgb ≥ 9.0 g/dL, Platelets ≥ 100 x 109/L, absolute neutrophil count of ≥ 1.0 x 109/L).
No evidence of any active secondary malignancy requiring ongoing treatment.
Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.
Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 must be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed if deemed safe and appropriate by the investigator, or if an alternative medication can be substituted.
Subjects currently taking herbal supplements containing AGN extract, including Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin must discontinue these or any other supplements containing these products 4 weeks prior to starting study drug.
Minimum age: 40
Subjects with distant metastatic cancer. Node-positive prostate cancer patients are allowed after completion of treatment.
Subjects who are receiving systemic treatments such as chemotherapy, androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens, or immunotherapy (checkpoint inhibitor).
Subjects who are receiving any other investigational agents. Participants will be excluded if they have any uncontrolled intercurrent illness at the discretion of the treating investigator. This may include, but is not limited to, the following conditions: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus (DM) with an HbA1C \>9, uncontrolled asthma, or psychiatric illness/social situations that would limit compliance with study requirements.
History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, or any other cardiac-related problem that would be considered a contraindication for participation in the opinion of the treating physician.
Any active secondary malignancy requiring treatment.
Chronic kidney disease with calculated GFR \<30 mL/min/1.73 m2 using Cockcroft-Gault formula, or measured GFR \<30 mL/min/1.73 m2 using a 24-hour urine collection. The hospital's lab measured GFR can be used if a 24-hour collection is not possible.
Subjects who are taking Warfarin/coumadin.
Recruiting status
Not Yet Recruiting
Estimated enrollment
45
Study start date
Mar 01, 2025
Study end date
Jan 01, 2028
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
PHASE1/PHASE2
Allocation
Na
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
N/A
Investigator:
Monika Joshi, MD
Publications
N/A
Websites
N/A
NCT06600698
Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
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