Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Amino Acids

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

* Ibrutinib 840 mg by mouth once daily for 2 weeks.
* Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib.

* Ibrutinib 840 mg by mouth once daily for 4 weeks.
* Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib

-Ibrutinib will be supplied by Pharmacyclics Inc.

Radical prostatectomy

Russell K Pachynski, M.D.

30-40% of patients who undergo radical prostatetecomy (RP) with curative intent for their localized prostate cancer experience relapse of their disease. Thus, improved therapeutic approaches are needed in this patient population. Enhancing the patient's anti-tumor immune response prior to surgery may improve long-term outcomes following RP

Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

A Phase 2 Study of Ibrutinib as Neoadjuvant Therapy in Patients With Localized Prostate Cancer

* CTCAE v.4.0
* DLTs will be defined as any of the following that are attributable to ibrutinib.

  * Any grade 4 toxicity, including hematologic toxicities with the exception of lymphocytosis. Lymphocytosis, in the absence of clinical symptoms, is excluded from DLT, as this may be considered an on-target pharmacodynamics effect of BTK inhibition.
  * Any grade 3 toxicity.
  * Any recurrence of the same grade 3 toxicity.
  * Any delay of RP due to study-drug related toxicity.
  * Any complications of RP (e.g., bleeding, delayed wound healing) deemed to be related to study drug.

Laboratory evaluations (\>/= 50% PSA decline)

Pathologic down-staging and/or pathologic T0

Pharmacyclics LLC.

Washington University School of Medicine

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Routine care in metastatic prostate cancer.

Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.

Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.

Radical Prostatectomy (RP)

Nicolaas Lumen, MD, PhD

The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.

Study Groups:

After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.

Follow-up:

Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.

Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established.

Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following:

* symptoms related to metastatic lesion(s)
* Prostate Specific Antigen (PSA) \> 50ng/ml and doubling time (PSA-DT) \< 6 months (starting 3 months after inclusion at earliest)

The estimated number of patients to be included in the local treatment arm is 40.

Local Treatment With RP for Newly-diagnosed mPCa

Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).

Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible.

Evaluation of cost \[€\] and quality-adjusted life years \[QALYs\] related to interventions needed in both arms from inclusion to death.

From date of inclusion until the date of Castration Refractory Prostate Cancer (CRPC) defined according to European Association of Urology (EAU) guidelines, or date of death from any cause, whichever came first, assessed up to 10 years. \[months\]

From date of inclusion until the date of any event related to local disease progression (eg ureter obstruction, bladder outlet obstruction), any Skeletal Related Event (SRE) or any event related to metastasis (eg lymphedema). \[months\]

From date of inclusion until the date of death from any cause, assessed up to 10 years. \[months\]

From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. \[months\]

Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire

From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) \[months\]

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer	NCT02643667	Prostate Cancer	Ibrutinib Radical prostat...	18 Years -	Washington University School of Medicine
Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer	NCT02643667	Prostate Cancer	Ibrutinib Radical prostat...	18 Years -	Washington University School of Medicine
Local Treatment With RP for Newly-diagnosed mPCa	NCT02138721	Prostatic Neopl... Neoplasm Metast...	Radical Prostat...	18 Years - 85 Years	University Hospital, Ghent

Spots Global Cancer Trial Database for radical prostatectomy (rp)