A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy

About This Trial

This clinical trial is testing whether adding an experimental immune-boosting drug to standard radiation and hormone therapy is safe and helps the body better fight prostate cancer.
It is designed for men with intermediate- or high-risk prostate cancer that has not spread to other parts of the body and who have not yet started treatment.
While all participants receive standard radiation and hormone therapy, only some will receive the new study drug given as three injections under the skin.
Patients considering this trial should know that participation lasts about seven months and requires regular clinic visits for blood tests, imaging scans, and a prostate tissue biopsy.

More Information

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: A physical exam Routine blood and urine tests Imaging scans of the chest, abdomen, and pelvis A bone scan A tumor biopsy 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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This clinical trial is testing whether adding an experimental immune-boosting drug to standard radiation and hormone therapy is safe and helps the body better fight prostate cancer.

Study Details

Start Date: June 12, 2023
Lead Sponsor: National Cancer Institute (NCI)

Full Eligibility Criteria

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 = 18 years old
ECOG performance status = 1,500/mcL, without CSF support
- platelets >= 100,000/mcL
- AST(SGOT)/ALT(SGPT) = 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 = 2.8 g/dL
Creatine = 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal by 24h urine
PT/INR and aPTT 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.