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Trial record 1 of 1 for:    NCT02102477
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Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer (SPCG-15)

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ClinicalTrials.gov Identifier: NCT02102477
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Olof Akre, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
Cause specific survival [ Time Frame: Up to 10 years ]
Cause-specific survival (CSS) will be calculated as "1-cause specific mortality. Mortality and mortality causes will be ascertained from the nationwide Cause-of-Death Register. In the absence of a functioning Cause-of-Death register, an endpoint committee of at least 2 medical doctors will determine the cause of death.
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • Metastasis free survival [ Time Frame: Up to 10 years ]
    Composite endpoint of time to metastasis and survival
  • Quality of life - general psychological, urinary, bowel and sexual health [ 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. Questions about self Questions about quality of life in the past month (scale 1 to 7; 1=no quality, 7=the best quality) Depression and anxiety (scale 1 to 7; 1=no, 7=very) Symptom Form (EPIC-26) (scale 1 to 5; 1= no problem, 5=major problem) Questions about the urinary tract Questions about sexual function Questions about bowel function Questions about prostate cancer - diagnosis and treatment Questions about prostate cancer check-ups Questions about hormone/castration therapy and its significance Questions about pain and lymph swelling
  • Overall survival [ Time Frame: Up to 10 years ]
    Overall survival (OS) will be calculated as "1-overall mortality. Mortality data will be ascertained through the nationwide Cause-of-Death Register.
  • Time to castration-resistant prostate cancer [ Time Frame: Up to 10 years ]
    Ascertained at follow-up visits
  • Time to biochemical progression [ Time Frame: Up to 10 years ]
    Ascertained at follow-up visits
  • Adverse events [ Time Frame: Up to 10 years ]
    Ascertained at visits
  • Cardiovascular disease [ Time Frame: Up to 10 years ]
    Data from national PcBaSe-register (https://snd.gu.se/en/catalogue/study/ext0014), a registry where the national prostate cancer registry (NPCR, www.npcr.se) has been linked to the Swedish National Cancer Register, the Cause of Death Register, the Prescribed Drug Register, the National Patient Register, and the Acute Myocardial Infarction Register, the Register of the Total Population, the Longitudinal Integration database for health insurance and labour market studies (LISA), the Multi-Generatioon Register and several other population-based registers.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • metastasis free survival [ Time Frame: Up to 10 years ]
    Composite endpoint of time to metastasis and survival
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2021)
  • Health-care consumption [ Time Frame: Annually up to 10 years ]
    Annual Defined Daily Dose (DDD) of analgesics, prescription databases
  • Health-care consumption [ Time Frame: Annually up to 10 years ]
    Annual number of days of hospitalization from patient registers
Original Other Pre-specified Outcome Measures
 (submitted: March 31, 2014)
Health-care consumption [ Time Frame: Annually up to 10 years ]
annual DDD of analesics annual number of days of hospitalization
 
Descriptive Information
Brief Title  ICMJE Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer
Official Title  ICMJE Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Procedure: Prostatectomy/Surgery
    Radical prostatectomy with or without adjuvant or salvage radiotherapy
  • Other: Radiotherapy with adjuvant androgen deprivation therapy
    Radiotherapy with adjuvant androgen deprivation therapy
Study Arms  ICMJE
  • Experimental: Prostatectomy/Surgery
    Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
    Intervention: Procedure: Prostatectomy/Surgery
  • Active Comparator: Radiotherapy with adjuvant androgen deprivation therapy
    Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy
    Intervention: Other: Radiotherapy with adjuvant androgen deprivation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2014)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2031
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≤75, at the time of randomization
  • Diagnosed histopathologically confirmed and untreated prostatic adenocarcinoma
  • The general condition and mental status of patients shall permit observation in accordance with the study protocol
  • Tumor stage (T, M, N):

T3 stage (as indicated by digital rectal examination or MR imaging or other validated imaging technique) T4 tumors can be included if considered resectable/treatable on MR imaging Significant extra-capsular tumor extension in biopsy (rare but acceptable for inclusion) M0 (no sign of distant metastases) confirmed by bone scan or CT or MRT of axial skeleton (at a maximum of pelvis and lumbar vertebral column) N0 stage, defined in accordance to the RECIST guidelines as no sign of macroscopic retroperitoneal lymph-node metastases >=1.5 cm (short axis) on CT scan, PET-CT, or MRT or more than one suspected lymph-node metastases Presence Gleason grade pattern 4 or 5

- Signed Informed consent

Exclusion Criteria:

  • Patients with a PSA value of > 100 ng/mL
  • Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives Patients with contraindications for either prostatectomy or radiotherapy to the prostate are not eligible for the study. Most contraindications for these treatments are relative, but in general, radiotherapy may be precluded among patients with:
  • Anorectal disease, such as fistulae, Crohn´s disease, and ulcerative colitis
  • Significant obstructive lower urinary tract symptoms
  • Proximal stricture of the urethrae
  • Severe neurogenic bladder dysfunction
  • Enlarged prostate beyond 70-90 ml
  • Previous radiotherapy to the pelvic region

On the other hand, surgery may be precluded among patients with:

  • Massive local tumor progression, particularly in the apical region
  • Massive abdominal obesity
  • Contraindications to anesthesia
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olof Akre, Prof. +46-8-517 700 00 olof.akre@ki.se
Listed Location Countries  ICMJE Denmark,   Finland,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02102477
Other Study ID Numbers  ICMJE SPCG-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Olof Akre, Karolinska University Hospital
Study Sponsor  ICMJE Olof Akre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Karolinska University Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP