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 : September 5, 2016
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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 |
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Prostatic Neoplasms | Procedure: Prostatectomy/Surgery Other: Radiotherapy with adjuvant androgen deprivation therapy | Not Applicable |
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 |

Arm | Intervention/treatment |
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Experimental: Prostatectomy/Surgery
Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
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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
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Other: Radiotherapy with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy |
- 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.
- 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.
- Health-care consumption [ Time Frame: Annually up to 10 years ]Annual Defined Daily Dose (DDD) of analesics annual number of days of hospitalization

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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 |
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

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
Contact: Olof Akre, Ass.prof. | +46-(0)8- 517 700000 | olof.akre@ki.se |
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 |
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 |
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 |
Prostatic neoplasms Locally advanced Radiotherapy Surgery Mortality |
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 |