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Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases (g-RAMPP)
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Purpose
| Condition | Intervention |
|---|---|
| Prostate Cancer | Procedure: Radical prostatectomy Drug: Androgen deprivation therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicentric, Prospective, Randomized Controlled Trial Comparing Radical Prostatectomy Plus Neoadjuvant Hormones With Androgen Deprivation Therapy Alone in the Management of Men With Pauci-metastatic Prostate Cancer |
- Cancer specific survival [ Time Frame: 5 years ]
- Developement of castration-resistance measured by PSA value [ Time Frame: 5 years ]
- Progression-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Quality of Life measured by the EPIC-26 [ Time Frame: 5 years ]
| Estimated Enrollment: | 452 |
| Study Start Date: | May 2015 |
| Estimated Study Completion Date: | April 2025 |
| Estimated Primary Completion Date: | April 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Radical prostatectomy and ADT
Hormone therapy plus radical prostatectomy with extended lymphadenectomy
|
Procedure: Radical prostatectomy
Study participants randomized in the intervention arm receive continuous hormone therapy in addition to radical prostatectomy with extended lymphadenectomy. It is not crucial whether the radical prostatectomy is performed open or robot-assisted.
Drug: Androgen deprivation therapy
For the antiandrogenic therapy a non-steroidal antiandrogen (eg, flutamide, bicalutamide) or a gonadotropin-releasing hormone (GnRH) analogues (e.g. goserelin, leuprolide) are available. The selection of standard hormone therapy is up to the judgment of the treating urologist. Other Name: Antihormonal treatment, hormonal therapy
|
|
Androgen deprivation therapy (ADT)
Androgen deprivation therapy
|
Drug: Androgen deprivation therapy
For the antiandrogenic therapy a non-steroidal antiandrogen (eg, flutamide, bicalutamide) or a gonadotropin-releasing hormone (GnRH) analogues (e.g. goserelin, leuprolide) are available. The selection of standard hormone therapy is up to the judgment of the treating urologist. Other Name: Antihormonal treatment, hormonal therapy
|
Detailed Description:
More recent data has shown that performing local therapy with lymphogenic metastatic prostate cancer has resulted in a definite benefit in carcinomaspecific and overall survival. The analysis of this data has led to a change of paradigm in the treatment of lymphogenic metastatic prostate cancer (Isbarn Deutsches Ärzteblatt 2013). Patients with low lymphogenic metastatic load and low comorbidity are therefore frequently given local therapy. In a retrospective review of patients with lympho-genic metastatic prostate cancer, who were either treated by means of systemic standard therapy or standard therapy plus radical prostatectomy, a highly significant benefit is shown for the patient group which was operated on (Engel et al., Eur Urol 2012). The 5 and 10 year overall survival rate in this cohort was 84% and 64% respectively following performance of RP and with standard therapy without RP was 60% and 28% respectively.
Our own working group was able to confirm this clear survival benefit in the lymphogenic metastatic stage for patients who had been operated on: in a matched pair analysis the clinically progression-free survival rate after 5 and 10 years was 77% and 61% respectively after additional RP and 61% and 31% respectively with standard therapy alone (p=0.005). The same trend was found for cancer-specific survival (84% and 76% with additional RP versus 81% and 46% with standard therapy alone (p=0.001) (Steuber et al., BJUI 2011).
The impressive improvements in the survival rates of lymphogenic metastatic prostate cancer through local therapy compared with systemic drug therapy alone suggests that patients with distant metastases could potentially also benefit from local therapy. Besides possible effects on tumour control, the RP could also be beneficial with regard to a local progression of the prostate cancer (rectal infiltration, infiltration of the bladder). This could lead to an improvement in the quality of life in the course of the disease. On the other hand, radical prostatectomy is associated with potential side-effects (e.g. urinary incontinence in approximately 5 - 10% of patients as well as the usual possible side-effects, such as thrombosis, embolism, disturbances to wound healing etc.), which can lead to a loss in terms of quality of life.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Patients with locally resectable intermediate and high-risk prostate cancer which has been confirmed by biopsy according to D'Amico criteria (intermediate risk: PSA 10-20 ng/ml, cT2b-c, Gleason score 7; high risk: PSA >20 ng/ml, >cT2c, Gleason score 8-10) with clinical evidence of bone metastases in imaging tests can be included. Necessary radiotherapy of the bone metastases as required is also permitted prior to inclusion in the study.
In line with the results from the recent CHAARTED and STAMPEDE studies (Sweeny et al., 2015, James et al 2015), early treatment with taxanes may be used in both the standard treatment arm as well as in the intervention arm where the prostatektomie is performed. The period 6 months from the initial diagnosis to randomization and possibly three months from randomization to surgery must be complied with.
Inclusion criteria
- Patients with newly diagnosed prostate cancer which has been confirmed by histological examination (within the last 6 months prior to randomization)
- At least one and at most 5 bone metastases in imaging tests (bone scintigraphy, CT, MRT or PET) at diagnosis with no evidence of visceral metastasis. Patients with evidence of lymph node metastasis (N1) are allowed
- PSA ≤ 200 ng/ml at diagnosis (without systemic therapy)
- Asymptomatic or mild symptomatic disease
- Locally resectable tumour stage
- ECOG Performance Score 0-1
- Submission of the patient's written declaration of informed consent following explanation
- Age ≥ 18 - ≤ 75 years
- Full legal capacity and compliance of the Patient
Exclusion Criteria:
- Contraindications to radical prostatectomy (Local non-resectable disease, increased anesthetic risk with co-morbidity)
- Detection of more than 5 bone metastases
- Pain management with opioid analgesics
- Evidence of visceral metastases or brain metastases
- Neuroendocrine and / or small cell differentiation in histology of the biopsy
- Charlson Comorbidity Index > 2
- ECOG Performance Score > 1
- Myocardial infarction or stroke within the last 6 months
- Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg, severe bone marrow aplasia) disease
- Severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
- Simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02454543
| Contact: Anke Renter | +4940741051300 | renter@martini-klinik.de |
| Germany | |
| Martini-Klinik am UKE GmbH | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Markus Graefen, Professor +4904741051300 graefen@martini-klinik.de | |
| Contact: Anke Renter +49047410533115 renter@martini-klinik.de | |
| Principal Investigator: | Markus Graefen, Professor | Martini-Klinik am UKE GmbH |
More Information
Publications:
| Responsible Party: | Martini-Klinik am UKE GmbH |
| ClinicalTrials.gov Identifier: | NCT02454543 History of Changes |
| Other Study ID Numbers: |
G-RAMPP_MK-2014 AP 75/13 ( Other Identifier: Arbeitsgemeinschaft urologische Onkologie ) |
| Study First Received: | May 8, 2015 |
| Last Updated: | August 12, 2016 |
Keywords provided by Martini-Klinik am UKE GmbH:
|
metastatic prostatectomy androgen deprivation |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones Estrogens, Conjugated (USP) Methyltestosterone Androgens Ascorbic Acid |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Vitamins Micronutrients Growth Substances Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |
ClinicalTrials.gov processed this record on July 14, 2017