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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 : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Olof Akre, Karolinska University Hospital

Study Description
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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
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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
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2045

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


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 - 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


  3. 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.

  4. Time to castration-resistant prostate cancer [ Time Frame: Up to 10 years ]
    Ascertained at follow-up visits

  5. Time to biochemical progression [ Time Frame: Up to 10 years ]
    Ascertained at follow-up visits

  6. Adverse events [ Time Frame: Up to 10 years ]
    Ascertained at visits

  7. 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.


Other Outcome Measures:
  1. Health-care consumption [ Time Frame: Annually up to 10 years ]
    Annual Defined Daily Dose (DDD) of analgesics, prescription databases

  2. Health-care consumption [ Time Frame: Annually up to 10 years ]
    Annual number of days of hospitalization from patient registers


Eligibility Criteria
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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.


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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
  • 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
Contacts and Locations
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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
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Contact: Olof Akre, Prof. +46-8-517 700 00 olof.akre@ki.se

Locations
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Sponsors and Collaborators
Olof Akre
Investigators
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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
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Responsible Party: Olof Akre, 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: March 31, 2022
Last Verified: March 2022
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs