G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer

Completed · Phase 2

Conditions studied: Prostatic Neoplasms

In brief

A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).

Key facts

Study ID

NCT02381236

Run by

GenSpera, Inc.

People needed

1

Starts

2016-02-01

Expected to finish

2017-02-01

Last updated by the study team

2017-02-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ECOG Performance Status < 2
• Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis
• Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3
• Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202
• Candidate for radical prostatectomy
• Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mm3)
• Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin < 2 mg/dL)
• Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN)
• Acceptable coagulation profile (no history of substantial non-iatrogenic bleeding diatheses, INR ≤ 2.3, aPTT ≤ 1.5 x ULN)
• Ejection fraction (LVEF) ≥ 45% measured by echocardiogram
• Willing to use acceptable methods of contraception to avoid pregnancy

You may not qualify if…

• Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
• Unable to tolerate mpMRI
• Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment
• Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma
• Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents
• Use of anti-coagulants is limited to local use for control of central line patency
• History or evidence of cardiac risk
• Uncontrolled cardiac or coronary artery disease
• Uncontrolled hypertension or hypertension requiring treatment with more than 2 anti-hypertensive agents
• Severe or uncontrolled medical disease
• Severe gastrointestinal bleeding within 12 weeks prior to treatment with G-202
• Known history of HIV, hepatitis B or hepatitis C
• Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids
• Documentation of keratosis follicularis
• Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
• Another primary malignancy, except non-melanoma skin cancer, that has not been in remission for at least 2 years.

Where it is running

• University of Texas Health Sciences Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.