Is NCT05361798 recruiting in Bethesda, MD?

Yes, NCT05361798 is currently recruiting participants at its Bethesda, MD location. This cancer of prostate clinical trial is actively enrolling qualified participants.

How do I join the cancer of prostate clinical trial in Bethesda?

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

Is participation in this Bethesda 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.

Cancer Of Prostate Clinical Trial in Bethesda, MD

About This Cancer Of Prostate Study in Bethesda

Background: Prostate cancer is often treated with radiation and ADT (ADT is androgen deprivation therapy). Up to 30% of these cancers recur within 5 years of treatment. Researchers want to see if a new drug (PDS01ADC) can help the immune system to fight prostate cancer. Objective: To find what doses of PDS01ADC are safe in people who are treated for prostate cancer. Also, to see what effects PDS01ADC has on the immune system. Eligibility: People aged 18 and older with high- and intermediate-risk prostate cancer. Their cancer must not have spread to other parts of the body. Design: The study will last 7 months. Participants will be screened. They will share their medical history. They will also have: \<TAB\>A physical exam \<TAB\>Routine blood and urine tests \<TAB\>Imaging scans of the chest, abdomen, and pelvis \<TAB\>A bone scan \<TAB\>A tumor biopsy \<TAB\>A specialized MRI. Participants will lie face down on the MRI scanner table. An antenna that receives a signal may be placed in the rectum. All participants will be treated with radiation therapy and ADT. Some participants will also receive PDS01ADC as an injection under the skin. This treatment will start 4 weeks after the radiation has ended. Participants will receive a total of 3 doses. The injections will be 4 weeks apart. Some screening tests will be repeated at each visit. Participants who do not receive PDS01ADC will also have screening tests during the treatment period. Participants will return for follow-up about 1 month after the last treatment or set of tests.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer:

Intermediate risk - Gleason 7 disease, PSA less than 10

High Risk - Gleason 8-10, PSA\>10, Extracapsular Extension

Participants must require treatment with SBRT to the prostate and ADT.

Pre-treatment tissue availability (collected \<= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient/unsuitable quality/quantity, a pre-treatment biopsy prior to initiation of study therapy will be required.

Male age \>= 18 years old

ECOG performance status \< 2

Participants must have adequate organ and marrow function as defined below:

absolute neutrophil count \>= 1,500/mcL, without CSF support

platelets \>= 100,000/mcL

AST(SGOT)/ALT(SGPT) \<= 2.5 X institutional upper limit of normal

Hgb \>= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb)

Total bilirubin \<= 1.5 x upper limit of normal (ULN), OR in participants with Gilbert s syndrome, a total bilirubin \<= 3.0

Serum albumin \>= 2.8 g/dL

Creatine \<= 1.5 X institutional ULN OR

Creatinine clearance \>= 50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal by 24h urine

PT/INR and aPTT \<= 1.5 X institutional ULN

Testosterone greater than 100 ng/dL.

Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last)

Participants must have prostate cancer accessible for biopsy

Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis).

Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion.

Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit).

Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.

Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication)

Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance.

Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness /social situations or other illnesses considered by the Investigator as high risk for investigational drug treatment

Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted.

Participants requiring requiring systemic corticosteroids (\>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed

Participants with HIV

Active Hepatitis B or Hepatitis C infection

Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)

History of allergic reactions attributed to compounds of similar chemical or biologic composition to PDS01ADC.

Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.

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 Bethesda?

Yes, this clinical trial (NCT05361798) has an active research site in Bethesda, 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.

Cancer Of Prostate Treatment Options in Bethesda, MD

If you're searching for cancer of prostate treatment options in Bethesda, MD, this clinical trial (NCT05361798) 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 Bethesda research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced cancer of prostate 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.

Cancer Of Prostate Clinical Trial in Bethesda, MD

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