The first-line treatment of locally advanced prostate cancer (clinical stage T3)


Does radical prostatectomy (with or without external beam radiation therapy) improve prostate-cancer specific survival by comparison with primary radiation treatment and androgen deprivation therapy (ADT) among patients initially diagnosed with locally advanced (T3) prostate cancer?

Over the years, in some European countries, it has proved possible to carry out clinical trials in prostate cancer that would probably never have been possible here in the USA. Researchers in Scandinavia have been working on another such trial since 2014: the Scandinavian Prostate Cancer Group 15 or SPCG-15 trial. The status of this trial was most recently reported by Stranne et al. in the Scandinavian Journal of Urology last December, and the trial protocol is listed on ClinicalTrials.gov (see here).

SPCG-15 is a prospective, multi-center, open-label, randomized, Phase III trial. Patients are randomized to either standard treatment (RT + ADT) or experimental treatment (RP with extended pelvic lymph-node dissection and with addition of adjuvant or salvage RT and/or ADT if deemed necessary) . Each participating center follows guidelines regarding the timing and dosing of postoperative RT and adjuvant treatment such as ADT. The primary endpoint is cause-specific survival. Secondary endpoints include metastasis-free and overall survival, quality-of-life, functional outcomes, and health-services requirements. Each subject will be followed for a minimum of 10 years.

The patients are being enrolled at 23 different centers in Denmark, Finland, Norway, and Sweden, all of which are well established and experienced in performing standard forms of treatment for localized prostate cancer.

The goal is to accrue a total of 1,200 men into this trial, and as of December 2018 there were > 400 patients already enrolled.

Specifically, to be enrolled into this trial, men must meet all of the following criteria:

  • ≤ 75 years of age at time of randomization
  • Newly diagnosed, untreated prostatic adenocarcinoma
  • A PSA level at diagnosis of < 100 ng/ml
  • Diagnosis based on at least 10 biopsy cores taken under systematic TRUS guidance
  • Clinical stage T3N0M0 disease, i.e., signifciant extracapsular extension of the prostate cancer but no evidence of distant metastases and no sign of macroscopic lymph-node metastases
  • A minimum of Gleason pattern 4 on biopsy, i.e., a Gleason score of at least 3 + 4 = 7 or higher
  • No other medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  • No history of any other cancer diagnosis (apart from non-melanoma skin cancer)

It is likely that this trial will not report meaningful results before at least 2024 or later. However, this clearly an important trial that may help us to establish a new and clear standard of care for the treatment of newly diagnosed, locally advanced prostate cancer. We understand that the investigators are currently confident that they will continue to be able to enroll patients rapidly into this trial.

 

4 Responses

  1. I wonder if they will allow (1) brachy boost therapy and (2) whole pelvic external beam radiation. The trial seems pointless if they are not using the best radiotherapy possible. I also think that all patients should be screened with a PSMA-based or Axumin PET scan to rule out pre-existing distant metastases.

  2. Allen:

    This trial would have been designed back in 2012/13, prior to any confirmation of the brachy boost data and prior to any availability of PET/CT scans, so I think the answer to your question is almost certainly no.

  3. The above link to “the status of this trial” is incorrect and not working.

  4. Sorry about that. The link has now been fixed.

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