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New treatment option for Cancer Of Prostate
Official title 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
ClinicalTrials.gov ID: NCT05361798
What this study is testing
What is PDS01ADC?
PDS01ADC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cancer of prostate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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...
- 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...
- Participants must have prostate cancer accessible for biopsy
- Ability of participant to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.