Baltimore, MDNCT07550517Now EnrollingIRB Ready

High-Risk Localized Prostate Cancer Clinical Trial in Baltimore, MD

Access cutting-edge high-risk localized prostate cancer treatment through this phase 2 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Expert Care in Baltimore

Access high-risk localized prostate cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related high-risk localized prostate cancer treatment provided free

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Check if you qualify for this high-risk localized prostate cancer clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This High-Risk Localized Prostate Cancer Study in Baltimore

This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \> 20 ng/mL.
Histologic confirmation of adenocarcinoma of the prostate.
Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \>10mm short axis by conventional CT size criteria.
Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \> 10.
Patient must qualify for definitive treatment of prostate cancer including EBRT as well as ADT (up to 45 days of prior ADT is allotted).
Patient must be ≥ 18 years of age.
Patient must have a life expectancy ≥ 24 months.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 6 weeks demonstrating:
Platelet count of \>100 x109/L
White blood cell (WBC) count \> 3,000/mL
Neutrophil count of \> 1,500/mL
Hemoglobin ≥ 10 g/dL
Estimated glomerular filtration rate (eGFR) \> 50 mL/min based upon Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA-617, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.
Total bilirubin \< 3 x ULN (except if confirmed history of Gilbert's disease)
Serum albumin \> 30 g/L
Aspartate aminotransferase (AST) \< 3 times the ULN
For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA-617.
Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Presence of a very high-risk feature: cT3b to T4 OR primary pattern 5 OR 2 to 3 high-risk features OR \>4 cores with Grade Group 4 or 5.
Any prior pharmacotherapy (with the exception of up to 45 days of ADT prior to randomization), radiation therapy, or surgery as treatment for prostate cancer. Any prior radiopharmaceutical therapy.
Any prior radiation to the pelvis.
Presence of N1 or M1 disease by conventional imaging (CT, MRI, and/or bone scan) or M1 disease by PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL). Lymph nodes with short axis \> 8 mm by CT will be considered N1 by conventional imaging.
Castration-resistant prostate cancer (CRPC).
Patient receiving any other investigational agents.
Patient is participating in a concurrent treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
Inadequate bone marrow reserve and organ function as detailed in 5.1.10.
Unable to lie flat during or tolerate PET/MRI, PET/CT or EBRT.
Concurrent serious medical condition that, in the opinion of the Investigator, would impair study participation.
Contraindication to receiving pelvic radiation, including history of or active inflammatory bowel disorders.
Refusal to sign informed consent.

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 Baltimore?

Yes, this clinical trial (NCT07550517) has an active research site in Baltimore, MD 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.

High-Risk Localized Prostate Cancer Treatment Options in Baltimore, MD

If you're searching for high-risk localized prostate cancer treatment options in Baltimore, MD, this clinical trial (NCT07550517) 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 Baltimore research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced high-risk localized 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 high-risk localized prostate cancer clinical trials near you to find additional studies recruiting in your area.

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