At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed localized intermediate or high risk prostate cancer
- ✓Intermediate risk: Gleason 7 disease, PSA <10
- ✓High risk: Gleason 8-10, PSA >10, or extracapsular extension
- ✓Requires treatment with SBRT to prostate and ADT
- ✕Evidence of distant metastatic disease or clinically/pathologically positive lymph nodes outside pelvis
- ✕Prior prostatectomy, focal therapy, or radiation to prostate
- ✕ADT or SBRT or pelvic nodal radiation initiated prior to trial enrollment
- ✕Live vaccine therapies within 30 days prior to treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PDS01ADC and Stereotactic Body Radiation Therapy (SBRT) for Cancer Of Prostate. Currently recruiting, targeting 65 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
De-escalating doses of PDS01ADC if appropriate + SBRT
Highest tolerated dose of PDS01ADC+SBRT
SBRT
Interventions
In 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.
SBRT 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