Is NCT06100705 recruiting in New Haven, CT?

Yes, NCT06100705 is currently recruiting participants at its New Haven, CT location. This metastatic castration-resistant prostate cancer clinical trial is actively enrolling qualified participants.

Is participation in this New Haven clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Castration-resistant Prostate Cancer Clinical Trial in New Haven, CT

Q: How do I join the metastatic castration-resistant prostate cancer clinical trial in New Haven?

To join this clinical trial in New Haven, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Metastatic Castration-resistant Prostate Cancer Study in New Haven

This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).

Sponsor: Yale University

Who Can Participate

Inclusion Criteria

Written informed consent obtained prior to the initiation of study procedures.

Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.

Histologically confirmed adenocarcinoma of the prostate.

Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).

Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:

By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.

By measurable disease: Progressive disease by RECIST v1.1 criteria

By non-measurable disease i. Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. ii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.

Castration status confirmed by serum testosterone level \<50ng/dL

ECOG Performance Status of 0 or 1.

Adequate liver function:

Bilirubin \<2.0 x institutional upper limit of normal (UNL)

AST (SGOT) \<2.5 x UNL

ALT (SGPT) \<2.5 x UNL

Acceptable renal function a) Serum creatinine \<2.0 x UNL

Acceptable hematologic function:

Absolute neutrophil count (ANC) \> 1.0 x10\^9 cells /L)

Platelet counts \> 100 x 10\^9 / L)

Hemoglobin \>9 g/dL

Exclusion Criteria

PSA \>20ng/dL within the 4 weeks prior to signing ICF

Previously treated with three or more FDA-approved androgen/AR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required.

Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.

Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.

Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.

Prior prednisone \>10mg (or its equivalent) within 2 weeks prior to registration.

Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.

Prior palliative radiotherapy within 2 weeks prior to registration.

Radiographic evidence of hepatic metastases

Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed.

Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids.

Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission.

Active infection requiring parenteral antibiotic therapy or causing fever (temperature \>100.5 in Fahrenheit scale) within 1 week prior to registration.

Life expectancy of less than 6 months prior to signing ICF.

Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Haven?

Yes, this clinical trial (NCT06100705) has an active research site in New Haven, CT that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Castration-resistant Prostate Cancer Treatment Options in New Haven, CT

If you're searching for metastatic castration-resistant prostate cancer treatment options in New Haven, CT, this clinical trial (NCT06100705) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Haven research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced metastatic castration-resistant prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic castration-resistant prostate cancer clinical trials near you to find additional studies recruiting in your area.

Metastatic Castration-resistant Prostate Cancer Clinical Trial in New Haven, CT

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