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Prostatic NeoplasmsSPCG-15NCT02102477

Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

A study testing Prostatectomy/Surgery and Radiotherapy with adjuvant androgen deprivation therapy in people with Prostatic Neoplasms, run by Olof Akre at 30 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Prostatectomy/Surgery and Radiotherapy with adjuvant androgen deprivation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
30 sitesin 4 countries
Study dates
Oct 2014to Dec 2045
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Olof Akre, Prof. contact

+46-8-517 700 00

olof.akre@ki.se

30 sites in 4 countries

Sweden16 sites, 15 recruiting

  • Falu Lasarett

    Falun, SE 791 82

    Hampus Nugin, MD

    Hampus Nugin, MD

    Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, SE-413 45

    Johan Stranne, ass prof

    Johan Stranne, M.D ass prof

    Recruiting

  • Helsingborgs Lasarett

    Helsingborg, SE 25187

    Konstantinos Lentaris, MD

    Konstantinos Lentaris, MD

    Recruiting

  • Länssjukhuset Ryhov

    Jönköping, SE 553 05

    Anders Jonsson, MD

    Anders Jonsson, MD

    Recruiting

  • Kirurgkliniken, Blekingesjukhuset

    Karlskrona, 371 41

    Amer Mousa Kadhem, M.D., +46 455 73 10 00

    Amer Mousa Kadhem, M.D.

    Recruiting

  • Linköping University Hospital

    Linköping

    Per Skoglund, M.D.

    Per Skoglund, M.D.

    Recruiting

  • Skåne University Hospital

    Malmö, SE 205 02

    Anders Bjartell, MD

    Anders Bjartell, MD

    Recruiting

  • Vrinevis Hospital

    Norrköping, SE 601 82

    Terminated

  • Östersund Hospital

    Östersund, SE 831 31

    Andreas Lundgren, MD

    Andreas Lundgren, MD

    Recruiting

  • Karolinska University Hospital

    Stockholm, SE 171 76

    Olof Akre, Prof

    Mats Olsson, MD

    Recruiting

  • Capio St Göran Hospital

    Stockholm

    Lillemor Nygren, M.D.

    Lillemor Nygren, M.D.

    Recruiting

  • Sundvalls Hospital

    Sundsvall

    Johan Styrke, M.D.

    Johan Styrke, M.D.

    Recruiting

  • Umeå University Hospital

    Umeå, SE 901 87

    Camilla Thellenberg, M.D PhD

    Camilla Thellenberg, M.D PhD

    Recruiting

  • Uppsala Akademiska Hospital

    Uppsala, SE 751 85

    Eva Johanssson, M.D

    Eva Johanssson, MD

    Recruiting

  • Centrallasarettet

    Vaxjo, SE 352 34

    Amer Elwaheidy, MD

    Amer Elwaheidy, MD

    Recruiting

  • Centrallasarettet Växjö Hospital

    Vaxjo

    Amer Elwaheidy, M.D.

    Amer Elwaheidy, M.D.

    Recruiting

Other trials in Sweden

Denmark6 sites, 6 recruiting

  • Aalborg University Hospital

    Aalborg

    Niels Harving, M.D.

    Niels Harving, M.D.

    Recruiting

  • Aarhus University Hospital

    Aarhus

    Lise Bentzen, M.D.

    Lise Bentzen, M.D.

    Recruiting

  • Rigshospitalet, Region h, Department Oncology

    Copenhagen, DK-2001

    Peter M Meidahl Petersen, M.D ass

    Peter M Meidahl Petersen, M.D ass prof

    Recruiting

  • Rigshopsitalet Department urology

    Copenhagen, SE- 2001

    Klaus Brasso, M.D

    Klaus Brasso, M.D

    Recruiting

  • Herlev Hospital

    Herlev

    Henrik Jacobsen, M.D.

    Henrik Jacobsen, M.D.

    Recruiting

  • Odense University Hospital

    Odense

    Steinbjørn Hansen, M.D.

    Steinbjørn Hansen, M.D.

    Recruiting

Other trials in Denmark

Norway5 sites, 5 recruiting

  • Sørlandet Hospital

    Kristiansand, 4604

    Christoph Müller, Ph.D. M.D.

    Christoph Müller, Ph.D. M.D

    Recruiting

  • Oslo University Hospital, Department of radiation Therapy

    Oslo, N-0424

    Wolfgang Lilleby, M.D ass prof

    Wolfang Lilleby, M.D ass prof

    Recruiting

  • Oslo University Hospital, Department Urology

    Oslo, N-0424

    Bjorn Brennhovd, M.D ass prof

    Bjorn Brennvold, M.D ass prof

    Recruiting

  • University Hospital of North Norway

    Tromsø

    Hege Sagstuen, Ph.D.

    Hege Sagstuen, Ph.D. M.D.

    Recruiting

  • St. Olavs Hospital

    Trondheim

    Torgrim Tandstad, Ph.D.

    Torgrim Tandstad, M.D.

    Recruiting

Other trials in Norway

Finland3 sites, 3 recruiting

  • Helsinki University Hospital, Department of Urology

    Helsinki, FIN-00290

    Antti Rannikko, M.D ass prof

    Antti Rannikko, M.D ass prof

    Recruiting

  • Tampere University Hospital, Pihlajalinna Koskiklinikka

    Tampere

    Teuvo Tammela, M.D.

    Teuvo Tammela, M.D.

    Recruiting

  • Turku University Hospital

    Turku

    Peter Boström, M.D.

    Peter Boström, M.D.

    Recruiting

Other trials in Finland

About this study

Official title: Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial

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.

Being tested
Prostatectomy/Surgery, Radiotherapy with adjuvant androgen deprivation therapy
Keywords
Prostatic neoplasms, Locally advanced, Radiotherapy, Surgery, Mortality
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostatectomy/SurgeryProcedure or surgery

    Radical prostatectomy with or without adjuvant or salvage radiotherapy

  • Radiotherapy with adjuvant androgen deprivation therapyOther

    Radiotherapy with adjuvant androgen deprivation therapy

Study groups in NCT02102477
Study groupRoleWhat they receive
Prostatectomy/SurgeryExperimentalPatients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
Receives: Procedure: Prostatectomy/Surgery
Radiotherapy with adjuvant androgen deprivation therapyActive comparatorPatients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy
Receives: Other: Radiotherapy with adjuvant androgen deprivation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cause specific survival

    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.

    Measured: Up to 10 years

Secondary outcomes (7)

  1. Metastasis free survival

    Composite endpoint of time to metastasis and survival

    Measured: Up to 10 years

  2. Quality of life - general psychological, urinary, bowel and sexual health

    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

    Measured: At 1,2,5 and 10 years after randomization

  3. Overall survival

    Overall survival (OS) will be calculated as "1-overall mortality. Mortality data will be ascertained through the nationwide Cause-of-Death Register.

    Measured: Up to 10 years

  4. Time to castration-resistant prostate cancer

    Ascertained at follow-up visits

    Measured: Up to 10 years

  5. Time to biochemical progression

    Ascertained at follow-up visits

    Measured: Up to 10 years

  6. Adverse events

    Ascertained at visits

    Measured: Up to 10 years

  7. Cardiovascular disease

    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.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2045 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02102477
Sponsor's protocol ID
SPCG-15
Acronym
SPCG-15
Status last verified
Mar 2022
First submitted
31 Mar 2014
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Prostatectomy/Surgery and Radiotherapy with adjuvant androgen deprivation therapy in people with Prostatic Neoplasms, run by Olof Akre at 30 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Sweden, Denmark, Norway, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olof Akre, Prof. (+46-8-517 700 00, olof.akre@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cause specific survival (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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