CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT04633252
Title field or adapter rule: {'original_value': 'A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:28.611459+00:00
Published At: 2026-10-29T00:00:00+00:00
Record Updated At: 2026-10-29
Source Retrieved At: 2026-10-31T22:18:05.512861+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Cancer Of Prostate", "Prostate Neoplasms"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-29", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT04633252"
protocolSection.identificationModule.officialTitle: "A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['1/Dose Escalation', '2/Safety Run-in (no longer applies; removed before enrollment)', '3/mCSPC: Dose Expansion', '4/mCRPC: Dose Expansion'], 'description': 'PDS01ADC at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.', 'name': 'PDS01ADC', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/Dose Escalation', '2/Safety Run-in (no longer applies; removed before enrollment)', '3/mCSPC: Dose Expansion', '4/mCRPC: Dose Expansion'], 'description': 'Docetaxel 75mg/m\\^2 will be administered intravenously every 21 days (i.e., a 3-week cycle) for up to 6 cycles in mCSPC and until progression or unacceptable toxicity in mCRPC.', 'name': 'Docetaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['2/Safety Run-in (no longer applies; removed before enrollment)'], 'description': 'M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.', 'name': 'M7824', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/Dose Escalation', '2/Safety Run-in (no longer applies; removed before enrollment)', '3/mCSPC: Dose Expansion', '4/mCRPC: Dose Expansion'], 'description': 'For mCSPC patients, prednisone is optional and if given, should be taken orally, at 5 mg once a day. For mCRPC patients, prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day as is the patient s preference.', 'name': 'Prednisone', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/Dose Escalation', '2/Safety Run-in (no longer applies; removed before enrollment)', '3/mCSPC: Dose Expansion', '4/mCRPC: Dose Expansion'], 'description': 'For mCSPC patients: Androgen Deprivation Therapy (ADT) may include GnRH agonist or monthly degarelix converted to GnRH agonist after 3 months. For mCRPC patients: ADT will be continued as per standard of care.', 'name': 'ADT', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

A recorded drug name is not by itself an indication or a condition-specific relationship.

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