Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02102477
Previous Study | Return to List | Next Study

Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer (SPCG-15)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102477
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Olof Akre, Karolinska University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate.

One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56)and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.

A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Prostatectomy/Surgery Other: Radiotherapy with adjuvant androgen deprivation therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Prostatectomy/Surgery
Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
 Procedure: Prostatectomy/Surgery
Radical prostatectomy with or without adjuvant or salvage radiotherapy
Active Comparator: Radiotherapy with adjuvant androgen deprivation therapy
Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy
 Other: Radiotherapy with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cause specific survival [ Time Frame: Up to 10 years ]
    Cause-specific survival (CSS), time to event. Cause-specific mortality data will be ascertained through the nationwide Cause-of-Death Register.


Secondary Outcome Measures :
  1. metastasis free survival [ Time Frame: Up to 10 years ]
    Composite endpoint of time to metastasis and survival

  2. Quality of life [ Time Frame: At 1,2,5 and 10 years after randomization ]
    Questionnaire-based evaluation of general psychological health, urinary health, bowel health, and sexual health.


Other Outcome Measures:
  1. Health-care consumption [ Time Frame: Annually up to 10 years ]
    Annual Defined Daily Dose (DDD) of analesics annual number of days of hospitalization


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≤75, at the time of randomization
  • Newly diagnosed prostatic adenocarcinoma morphologically confirmed and untreated
  • The transrectal ultrasound (TRUS-guided) biopsy with at least 10 cores (regarding handling of biopsies)
  • The general condition and mental status of patients shall permit observation in accordance with the study protocol
  • Tumor stage (T, M, N):

T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) N0 (no sign of macroscopic lymph-node metastases)

  • Presence Gleason grade pattern 4
  • Eligible for either treatment
  • Signed Informed consent

Exclusion Criteria:

  • Patients with a PSA value of > 100 ng/mL
  • Patients with a history of other cancer diagnoses (apart from non-melanoma skin cancer)
  • Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR < 30 ml/ml or elevated liver transaminases above > 10 ULN
  • Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT02102477


Contacts
Layout table for location contacts
Contact: Olof Akre, Ass.prof. +46-(0)8- 517 700000 olof.akre@ki.se

Locations
Layout table for location information
Denmark
Rigshospitalet, Region h, Department Oncology Recruiting
Copenhagen, Denmark, DK-2001
Contact: Peter M Meidahl Petersen, M.D ass         
Principal Investigator: Peter M Meidahl Petersen, M.D ass prof         
Rigshopsitalet Department urology Not yet recruiting
Copenhagen, Denmark, SE- 2001
Contact: Klaus Brasso, M.D         
Principal Investigator: Klaus Brasso, M.D         
Finland
Helsinki University Hospital, Department of Urology Recruiting
Helsinki, Finland, FIN-00290
Contact: Antti Rannikko, M.D ass prof         
Principal Investigator: Antti Rannikko, M.D ass prof         
Principal Investigator: Mauri Kouri, M.D PhD         
Principal Investigator: Tuomas Mirtti, M.D PhD         
Norway
Oslo University Hopsital, Department Urology Recruiting
Nydalen-Oslo, Norway, N-0424
Contact: Bjorn Brennhovd, M.D ass prof         
Principal Investigator: Bjorn Brennvold, M.D ass prof         
Oslo University Hospital, Department of radiation Therapy Recruiting
Nydalen-Oslo, Norway, N-0424
Contact: Wolfgang Lilleby, M.D ass prof         
Principal Investigator: Wolfang Lilleby, M.D ass prof         
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE-413 45
Contact: Johan Stranne, ass prof         
Principal Investigator: Johan Stranne, M.D ass prof         
Umeå University Hospital Not yet recruiting
Umeå, Sweden, SE 901 87
Contact: Camilla Thellenberg, M.D PhD         
Principal Investigator: Camilla Thellenberg-Karlsson, M.D PhD         
Uppsala Akademiska Hospital Recruiting
Uppsala, Sweden, SE 751 85
Contact: Eva Johanssson, M.D       eva.m.johansson@akademiska.se   
Sponsors and Collaborators
Olof Akre
Investigators
Layout table for investigator information
Principal Investigator: Johan Stranne, M.D ass prof Sahlgrenska University Hospital, Department of Urology, SE- 413 45 Gothenburg
Principal Investigator: Camilla Thellenberg Karlsson, MD, PhD Umeå University Hospital, Department of Radiation Science, SE-901 87 Umeå Sweden
Principal Investigator: Eva M Johansson, R.N PhD Karolinska Institute, Nobelsväg, SE- 171 77 Solna, Sweden
Principal Investigator: Gunnar Steineck, M.D Prof Karolinska Institute, Nobelsväg, SE-171 77 Solna, Sweden
Principal Investigator: Klaus Brasso, M.D Rigshospitalet, department Urology, DK-2001-Copenhagen, Denmark
Principal Investigator: Peter M Meidahl Petersen, M.D ass prof Rigshospitalet, Region h, Department of Oncology, Blegdamsvej 9, DK- 2001, Copenhagen, Denmark
Principal Investigator: Bjørn Brennhovd, M.D ass.prof Oslo University Hospital, Department of Urology, P.O Box 4950 Nydalen, N-0424, Oslo Norway
Principal Investigator: Wolfgang Lilleby, M.D ass.prof Oslo University Hospital, Department of Radiation Therapy, P.O Box 4950, N-0424, Nydalen Oslo, Norway
Principal Investigator: Antti Rannikko, M.D ass.prof Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
Principal Investigator: Mauri Kouri, M.D PhD Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
Principal Investigator: Tuomas Mirtti, M.D PhD Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Olof Akre, Associate professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02102477    
Other Study ID Numbers: SPCG-15
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Olof Akre, Karolinska University Hospital:
Prostatic neoplasms
Locally advanced
Radiotherapy
Surgery
Mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs