Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy (ADAM)
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|ClinicalTrials.gov Identifier: NCT04295447|
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : January 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Other: Standard of care Drug: Apalutamide 60Mg Tab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Phase 2 Study of Adjuvant Apalutamide or Standard of Care in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy|
|Actual Study Start Date :||December 10, 2020|
|Estimated Primary Completion Date :||May 31, 2027|
|Estimated Study Completion Date :||May 31, 2027|
Standard of care
Other: Standard of care
30 cycles apalutamide 240 mg (4 x 60 mg) once daily on days 1-28 of a 28-day cycle in addition to standard of care
Other: Standard of care
Drug: Apalutamide 60Mg Tab
(4 x 60 mg) once daily on days 1-28 of a 28-day cycle
- Progression-free survival (PFS). [ Time Frame: From date of randomization until the date of first documented progression (BCR or metastases) or date of death from any cause, whichever came first, assessed up to 7 years" ]
This endpoint is defined as time interval from randomization until BCR (irrespective of the PSADT), metastases, or death from any cause, whichever occurs first. BCR is defined as a PSA ≥ 0.2 ng/ml that has risen on at least two separate occasions at least four weeks ± 3 days apart and measured by the central PSA-lab. The time of BCR is then backdated to the time of the first increased PSA measurement.
Metastatic disease will be defined as the presence of bone metastases visualized on bone scan prostate cancer working group 3 (PCWG3)-criteria; and/or visceral (e.g. liver, lung, brain) or extra-pelvic nodal metastases visualized on CT scan (or MRI scan) (RECIST 1.1-criteria). Evaluations will be performed every 6 months once BCR occurred or sooner if clinically indicated.
For a patient with none of these events before the end of follow-up, observation of PFS will be censored at the date of his date of last contact.
- PSA doubling time (PSADT) [ Time Frame: If BCR occurs up to 6 months later ]
In case of a BCR, PSA kinetics as the PSADT are calculated based on the monthly PSA measurements during the first six months after the BCR. The values used to determine the BCR are included in the calculation of PSA kinetics as well.
PSADT is calculated according to Pound et al. by the natural log of 2 (0.693) divided by the slope of the relationship between the log of PSA and time of PSA measurement (i.e. time from BCR) for each patient . PSADT can also be assessed using the MSKCC PSADT calculator (https://www.mskcc.org/nomograms/prostate/psa_doubling_time) using the above definitions.
- Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: From date the informed consent is signed until BCR occured and PSADT was calculated or when distant metastasis occurred (both with or without BCR) or date of death from any cause, whichever came first, assessed up to 7 years. ]Safety and tolerability assessed on the basis of adverse events, more precisely adverse events, serious adverse events, adverse reactions, and serious adverse reactions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295447
|Contact: Martin Bögemann, Univ.-Prof. Dr. email@example.comfirstname.lastname@example.org|
|University Hospital Münster||Recruiting|
|Münster, North Rhine-Westfalia, Germany, 48149|
|Contact: Martin Bögemann, Univ.-Prof. Dr. med.|
|Principal Investigator:||Martin Bögemann, Univ.-Prof. Dr. med.||Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie|