Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases

NCT02454543 | Active Not Recruiting

• 2 other identifiers: G-RAMPP_MK-2014AP 75/13
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate, the effect of radical prostatectomy with extended lymphadenectomy on cancer-specific survival, time to castration-resistance, time to progression and quality of life in patients with a limited bone metastatic prostate cancer. In addition the influence of patient- and disease-related factors on clinical outcome (prognostic effect) and on the comparison therapy (predictive effect) will be examined. Amendment05: Due to the slow tumor biology of prostate cancer, the follow-up period of 5 years is not sufficient to reach the primary endpoint of the study. For this reason, the follow-up is extended for a further 5 years with 2 visits per year.

Conditions

Prostate Cancer

Keywords

metastatic; prostatectomy; androgen deprivation; best systemic therapy

Outcome Measures

Primary Outcomes (1)

• Cancer specific survival

  Follow-up visits every 3 months

  10 years

Secondary Outcomes (3)

• Developement of castration-resistance measured by PSA value

  10 years

• Overall survival

  10 years

• Progression-free survival

  10 years

Other Outcomes (1)

• Quality of Life measured by the EPIC-26

  10 years

Study Arms (2)

Radical prostatectomy and BST

OTHER

BST plus radical prostatectomy with ext. lymphadenectomy

Procedure: Radical prostatectomy

Best Systemic Therapy (BST)

OTHER

e.g. Androgen deprivation therapy, chemotherapy, others

Drug: Best systemic therapy

Interventions

Radical prostatectomy PROCEDURE

Study participants randomized in the intervention arm receive best systemic therapy in addition to radical prostatectomy with extended lymphadenectomy. It is not crucial whether the radical prostatectomy is performed open or robot-assisted.

Radical prostatectomy and BST

Best systemic therapy DRUG

For the antiandrogenic therapy a non-steroidal antiandrogen (e.g. flutamide, bicalutamide) or a gonadotropin-releasing hormone (GnRH) analogues (e.g. goserelin, leuprolide) are available. The selection of best systemic therapy is up to the judgment of the treating urologist.

Also known as: Androgen deprivation therapy, chemotherapy, others

Best Systemic Therapy (BST)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ADT)
• 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

You may not qualify if:

• Contraindications to radical prostatectomy (Local non-resectable disease, increased anesthetic risk due to comorbidities)
• Detection of more than 5 bone metastases
• Pain management with opioid analgetics
• 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 disease (e.g. severe bone marrow aplasia)
• 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

Sponsors & Collaborators

• Martini-Klinik am UKE GmbH: lead
• Förderverein Hilfe bei Prostatakrebs e.V.: collaborator

Study Sites (1)

Markus Graefen

Hamburg, Nein, 20246, Germany

Location

Related Publications (13)

• Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.

  PMID: 24207135 BACKGROUND

• Schellhammer PF, Venner P, Haas GP, Small EJ, Nieh PT, Seabaugh DR, Patterson AL, Klein E, Wajsman Z, Furr B, Chen Y, Kolvenbag GJ. Prostate specific antigen decreases after withdrawal of antiandrogen therapy with bicalutamide or flutamide in patients receiving combined androgen blockade. J Urol. 1997 May;157(5):1731-5.

  PMID: 9112515 BACKGROUND

• Isbarn H, Huland H, Graefen M. Results of radical prostatectomy in newly diagnosed prostate cancer: long-term survival rates in locally advanced and high-risk cancers. Dtsch Arztebl Int. 2013 Jul;110(29-30):497-503. doi: 10.3238/arztebl.2013.0497. Epub 2013 Jul 22.

  PMID: 24000298 BACKGROUND

• Engel J, Bastian PJ, Baur H, Beer V, Chaussy C, Gschwend JE, Oberneder R, Rothenberger KH, Stief CG, Holzel D. Survival benefit of radical prostatectomy in lymph node-positive patients with prostate cancer. Eur Urol. 2010 May;57(5):754-61. doi: 10.1016/j.eururo.2009.12.034. Epub 2010 Jan 20.

  PMID: 20106588 BACKGROUND

• Steuber T, Budaus L, Walz J, Zorn KC, Schlomm T, Chun F, Ahyai S, Fisch M, Sauter G, Huland H, Graefen M, Haese A. Radical prostatectomy improves progression-free and cancer-specific survival in men with lymph node positive prostate cancer in the prostate-specific antigen era: a confirmatory study. BJU Int. 2011 Jun;107(11):1755-61. doi: 10.1111/j.1464-410X.2010.09730.x. Epub 2010 Oct 13.

  PMID: 20942833 BACKGROUND

• Widmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fossa SD; Scandinavian Prostate Cancer Group Study 7; Swedish Association for Urological Oncology 3. Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial. Lancet. 2009 Jan 24;373(9660):301-8. doi: 10.1016/S0140-6736(08)61815-2. Epub 2008 Dec 16.

  PMID: 19091394 BACKGROUND

• Zelefsky MJ, Eastham JA, Cronin AM, Fuks Z, Zhang Z, Yamada Y, Vickers A, Scardino PT. Metastasis after radical prostatectomy or external beam radiotherapy for patients with clinically localized prostate cancer: a comparison of clinical cohorts adjusted for case mix. J Clin Oncol. 2010 Mar 20;28(9):1508-13. doi: 10.1200/JCO.2009.22.2265. Epub 2010 Feb 16.

  PMID: 20159826 BACKGROUND

• Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W; NCIC CTG PR.3/MRC UK PR07 investigators. Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial. Lancet. 2011 Dec 17;378(9809):2104-11. doi: 10.1016/S0140-6736(11)61095-7. Epub 2011 Nov 2.

  PMID: 22056152 BACKGROUND

• Cooperberg MR, Vickers AJ, Broering JM, Carroll PR. Comparative risk-adjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer. Cancer. 2010 Nov 15;116(22):5226-34. doi: 10.1002/cncr.25456.

  PMID: 20690197 BACKGROUND

• Wirth M, Tammela T, Cicalese V, Gomez Veiga F, Delaere K, Miller K, Tubaro A, Schulze M, Debruyne F, Huland H, Patel A, Lecouvet F, Caris C, Witjes W. Prevention of bone metastases in patients with high-risk nonmetastatic prostate cancer treated with zoledronic acid: efficacy and safety results of the Zometa European Study (ZEUS). Eur Urol. 2015 Mar;67(3):482-91. doi: 10.1016/j.eururo.2014.02.014. Epub 2014 Feb 20.

  PMID: 24630685 BACKGROUND

• James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.

  PMID: 26719232 BACKGROUND

• Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. doi: 10.1056/NEJMoa1503747. Epub 2015 Aug 5.

  PMID: 26244877 BACKGROUND

• Graefen M, Falkenbach F, Maurer T, Budaus L, Tilki D, Karakiewicz PI, Aly M, Wiklund P, Brasso K, Roder A, Poulsen MH, Schostak M, Gortzen C, Renter A, von Amsberg G, Haese A, Heinzer H, Salomon G, Steuber T, Beyer B. Best Systemic Therapy With or Without Radical Prostatectomy in the Management of Men With Oligometastatic Prostate Cancer: The RAMPP Randomised Controlled Trial. Eur Urol. 2025 Oct 3:S0302-2838(25)04687-1. doi: 10.1016/j.eururo.2025.09.4144. Online ahead of print.

  PMID: 41046179 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Androgen Antagonists; Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Officials

• Markus Graefen, Professor

  Martini-Klinik am UKE GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

DE (1)