Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT (NCT03007732) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT
United States23 participantsStarted 2017-05-17
Plain-language summary
This is a non-comparative open-label multicenter Phase 2 clinical trial combining stereotactic body radiation therapy (SBRT) and pembrolizumab with or without intratumoral SD-101 in participants with newly diagnosed hormone-naive oligometastatic prostate cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be \>=18 years of age on day of signing informed consent.
✓. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
✓. Histologically documented adenocarcinoma of the prostate
✓. Oligometastatic disease. In order to be eligible, the participant must have a total of \<4 metastatic bone and/or metastatic lymph node sites based on bone and/or soft tissue lesions as defined by any of the following:
✓. Bone metastases will be defined by bone imaging. If the participant has technetium bone scan, and/or sodium fluoride (NaF) PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For participants undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
✓. Distant metastatic lymph node disease. A lymph node ≥1 cm in shortest dimension will be noted as involved with disease. Distant metastatic lymph nodes will be determined as any lymph nodes outside the confines of the true pelvis. For participants undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
✓. Any other soft tissue lesion deemed by the physician to be consistent with distant metastatic disease. For participants undergoing PSMA PET, only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
Exclusion criteria
What they're measuring
1
Change Rate of Prostate-specific Antigen (PSA) < Nadir + 2 ng/mL From First Day of Treatment to 15 Months (Cohort 2)
Timeframe: Start of treatment and 15 months (approx. 15 months total)
2
Number of Participants With Treatment-related Adverse Events
✕. Participants who are not appropriate candidates for prostate or oligometastasis-directed SBRT
✕. Participants with neuroendocrine or small cell features are not eligible.
✕. Participants with evidence of liver metastasis are excluded.
✕. Gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists (e.g., leuprorelin, degarelix) for \> 2 months prior to consenting
✕. Antiandrogens (e.g., bicalutamide, flutamide, nilutamide, abiraterone, enzalutamide) for \> 2 months prior to consenting. Participants on 5-alpha reductase inhibitors are allowed on study.
✕. Estrogen containing compounds for \> 2 months prior to consenting
✕. PC-SPES or PC-x products. Other herbal therapies or supplements will be considered by the Principle Investigator on a case-by-case basis based on their potential for hormonal or anti-cancer therapies.
✕. Prior immunotherapy or chemotherapy for prostate cancer