SPCG-15: Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

Sponsor
Olof Akre (Other)
Overall Status
Recruiting
CT.gov ID
NCT02102477
Collaborator
(none)
1,200
30
2
374
40
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Study Details

Study Description

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
  • Procedure: Prostatectomy/Surgery
  • Other: Radiotherapy with adjuvant androgen deprivation therapy
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2045

Arms and Interventions

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

Primary Outcome Measures

  1. Cause specific survival [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 [Up to 10 years]

    Composite endpoint of time to metastasis and survival

  2. Quality of life - general psychological, urinary, bowel and sexual health [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 [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 [Up to 10 years]

    Ascertained at follow-up visits

  5. Time to biochemical progression [Up to 10 years]

    Ascertained at follow-up visits

  6. Adverse events [Up to 10 years]

    Ascertained at visits

  7. Cardiovascular disease [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 [Annually up to 10 years]

    Annual Defined Daily Dose (DDD) of analgesics, prescription databases

  2. Health-care consumption [Annually up to 10 years]

    Annual number of days of hospitalization from patient registers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Aalborg University Hospital Aalborg Denmark
2 Aarhus University Hospital Aarhus Denmark
3 Rigshospitalet, Region h, Department Oncology Copenhagen Denmark DK-2001
4 Rigshopsitalet Department urology Copenhagen Denmark SE- 2001
5 Herlev Hospital Herlev Denmark
6 Odense University Hospital Odense Denmark
7 Helsinki University Hospital, Department of Urology Helsinki Finland FIN-00290
8 Tampere University Hospital, Pihlajalinna Koskiklinikka Tampere Finland
9 Turku University Hospital Turku Finland
10 Sørlandet Hospital Kristiansand Norway 4604
11 Oslo University Hospital, Department of radiation Therapy Oslo Norway N-0424
12 Oslo University Hospital, Department Urology Oslo Norway N-0424
13 University Hospital of North Norway Tromsø Norway
14 St. Olavs Hospital Trondheim Norway
15 Falu Lasarett Falun Sweden SE 791 82
16 Sahlgrenska University Hospital Göteborg Sweden SE-413 45
17 Helsingborgs Lasarett Helsingborg Sweden SE 25187
18 Länssjukhuset Ryhov Jönköping Sweden SE 553 05
19 Kirurgkliniken, Blekingesjukhuset Karlskrona Sweden 371 41
20 Linköping University Hospital Linköping Sweden
21 Skåne University Hospital Malmö Sweden SE 205 02
22 Vrinevis Hospital Norrköping Sweden SE 601 82
23 Karolinska University Hospital Stockholm Sweden SE 171 76
24 Capio St Göran Hospital Stockholm Sweden
25 Sundvalls Hospital Sundsvall Sweden
26 Umeå University Hospital Umeå Sweden SE 901 87
27 Uppsala Akademiska Hospital Uppsala Sweden SE 751 85
28 Centrallasarettet Växjö Sweden SE 352 34
29 Centrallasarettet Växjö Hospital Växjö Sweden
30 Östersund Hospital Östersund Sweden SE 831 31

Sponsors and Collaborators

  • Olof Akre

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olof Akre, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02102477
Other Study ID Numbers:
  • SPCG-15
First Posted:
Apr 3, 2014
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Olof Akre, Professor, Karolinska University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022