Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

NCT02102477 | Recruiting DMC

• 1 other identifier: SPCG-15
• Study Type: interventional
• Target: 1,200
• Locations: 4 countries
• Sites: 30

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.

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasms; Locally advanced; Radiotherapy; Surgery; Mortality

Outcome Measures

Primary Outcomes (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.

  Up to 10 years

Secondary Outcomes (7)

• Metastasis free survival

  Up to 10 years

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

  At 1,2,5 and 10 years after randomization

• Overall survival

  Up to 10 years

• Time to castration-resistant prostate cancer

  Up to 10 years

• Time to biochemical progression

  Up to 10 years

Other Outcomes (2)

• Health-care consumption

  Annually up to 10 years

• Health-care consumption

  Annually up to 10 years

Study Arms (2)

Prostatectomy/Surgery

EXPERIMENTAL

Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy

Procedure: Prostatectomy/Surgery

Radiotherapy with adjuvant androgen deprivation therapy

ACTIVE COMPARATOR

Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy

Other: Radiotherapy with adjuvant androgen deprivation therapy

Interventions

Prostatectomy/Surgery PROCEDURE

Radical prostatectomy with or without adjuvant or salvage radiotherapy

Prostatectomy/Surgery

Radiotherapy with adjuvant androgen deprivation therapy OTHER

Radiotherapy with adjuvant androgen deprivation therapy

Radiotherapy with adjuvant androgen deprivation therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• \- Signed Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Olof Akre: lead

Study Sites (30)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet, Region h, Department Oncology

Copenhagen, DK-2001, Denmark

RECRUITING

Rigshopsitalet Department urology

Copenhagen, SE- 2001, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Helsinki University Hospital, Department of Urology

Helsinki, FIN-00290, Finland

RECRUITING

Tampere University Hospital, Pihlajalinna Koskiklinikka

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Sørlandet Hospital

Kristiansand, 4604, Norway

RECRUITING

Oslo University Hospital, Department of radiation Therapy

Oslo, N-0424, Norway

RECRUITING

Oslo University Hospital, Department Urology

Oslo, N-0424, Norway

RECRUITING

University Hospital of North Norway

Tromsø, Norway

RECRUITING

St. Olavs Hospital

Trondheim, Norway

RECRUITING

Falu Lasarett

Falun, SE 791 82, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

RECRUITING

Helsingborgs Lasarett

Helsingborg, SE 25187, Sweden

RECRUITING

Länssjukhuset Ryhov

Jönköping, SE 553 05, Sweden

RECRUITING

Kirurgkliniken, Blekingesjukhuset

Karlskrona, 371 41, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skåne University Hospital

Malmo, SE 205 02, Sweden

RECRUITING

Vrinevis Hospital

Norrköping, SE 601 82, Sweden

TERMINATED

Östersund Hospital

Östersund, SE 831 31, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, SE 171 76, Sweden

RECRUITING

Capio St Göran Hospital

Stockholm, Sweden

RECRUITING

Sundvalls Hospital

Sundsvall, Sweden

RECRUITING

Umeå University Hospital

Umeå, SE 901 87, Sweden

RECRUITING

Uppsala Akademiska Hospital

Uppsala, SE 751 85, Sweden

RECRUITING

Centrallasarettet

Vaxjo, SE 352 34, Sweden

RECRUITING

Centrallasarettet Växjö Hospital

Vaxjo, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prostatectomy; Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olof Akre, Prof.

CONTACT

+46-8-517 700 00; olof.akre@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2045
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (6); NO (5); SE (16); FI (3)