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NCT Number: NCT02102477

Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatectomy/Surgery

Procedure

Radical prostatectomy with or without adjuvant or salvage radiotherapy

Radiotherapy with adjuvant androgen deprivation therapy

Other

Radiotherapy with adjuvant androgen deprivation therapy

Primary outcomes

  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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Olof Akre, Prof.

CONTACT

[email protected]

+46-8-517 700 00

Sponsors and collaborators

Lead sponsor

Olof Akre

Other

Registry information

Official study title

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

Acronym: SPCG-15

Important dates

Study start
2014
Primary completion
2025
Study completion
2045
First posted
Apr 3, 2014
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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