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.
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.
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.
Parallel
PDS01ADC
DrugIn the safety lead in, PDS01ADC will be given in de-escalating doses (starting dose 16.8 mcg/kg, and de-escalated if needed to 12 mcg/kg, or 8 mcg/kg) every 4 weeks for 3 doses. Within 4 weeks after completing SBRT, those participants receiving immunotherapy agents will receive PDS01ADC by subcutaneous injection at dose determined during the safety lead in every 4 weeks for 3 doses.
Stereotactic Body Radiation Therapy (SBRT)
RadiationSBRT to the prostate will be delivered in 5 fractions of radiation each of 7.25-8.0 Gy, every other day over the course of 10 business days (2-3 weeks). The total dose will be 36.25-40 Gy
To determine safety and tolerated doses of PDS01ADC and SBRT
For the safety lead-in: grade and type of toxicities at each dose level will be assessed to determine safety and tolerated doses of PDS01ADC in combination with SBRT in participants with high and intermediate risk prostate cancer receiving standard of care ADT
evaluate T-cell clonality as measures of immunologic activity
Relative T-cell antigen receptor (TCR) clonality for each participant will be formed and these ratios will be compared between the two arms.
Evaluate peripheral immune response
Immune cell subsets will be evaluated to determine peripheral immune response and compare between the two arms
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