E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to determine if the addition of JNJ-56021927 to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or OS for subjects with low-volume mHSPC. |
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E.2.2 | Secondary objectives of the trial |
*To evaluate clinically relevant improvements with addition of JNJ-56021927 to ADT including delays in pain progression and opioid use for prostate cancer, skeletal-related events, and the need for cytotoxic chemotherapy
*To characterize the safety of adding JNJ-56021927 to ADT in subjects with low-volume mHSPC
*To characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-56021927
*To evaluate the concentration of leuprolide and assess the PD effect of leuprolide on testosterone concentrations when used alone or in combination with JNJ-56021927 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization, histologic evidence of prostate adenocarcinoma from a metastatic lesion is required
- Metastatic disease documented by >= 2 bone lesions on 99mTc bone scan
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0, 1, or 2
- Allowed prior treatment for prostate cancer:
a) Maximum of 1 course of radiation or surgical intervention;
b) Up to 6 cycles of docetaxel for low-volume disease with the last dose within 2 months of randomization;
c) Must not have experienced disease progression between the last dose of docetaxel and Screening;
d) Participants who did not receive prior docetaxel may have received less than or equal to (<=) 3 months of ADT in the metastatic disease setting prior to randomization. Participants who received prior docetaxel may have received <= 6 months ADT in the metastatic setting prior to randomization;
e) May also have received up to 6 months of GnRHa in the adjuvant or neo-adjuvant setting as long as it was completed greater than (>)1 year prior to randomization; f) May have received radiation therapy or prostatectomy as definitive therapy |
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E.4 | Principal exclusion criteria |
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
- Known brain metastases
- Lymph nodes as only site of metastasis
- Visceral metastasis observed on computed tomography (CT)/magnetic resonance imaging (MRI) or >= 4 bone lesions on 99mTc bone scan with at least 1 lesion beyond the pelvis or vertebral column
- Any prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
- Prior treatment with other second generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
- History of seizures or medications known to lower seizure threshold |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Radiographic Progression-Free Survival (rPFS)
- Overall Survival (OS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Up to 76 Months
- Up to 76 Months |
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E.5.2 | Secondary end point(s) |
- Time to Pain Progression
- Time to Skeletal-Related Event (SRE)
- Time to Chronic Opioid Use
- Time to Initiation of Cytotoxic Chemotherapy |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Up to 76 Months
- Up to 76 Months
- Up to 76 Months
- Up to 76 Months |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarkers and tumour response assessments |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
China |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Poland |
Romania |
Russian Federation |
Spain |
Sweden |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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EoT Visit is within 30 days after the last dose of study drug for all subjects. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 4 |