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Early Rising PSA Endocrine Treatment Versus Chemo-endocrine Therapy- SPCG14

12. august 2021 oppdatert av: Andreas Josefsson, Göteborg University

A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation +/- Taxotere (Docetaxel) for Non-metastatic Prostate Cancer Patients With a Rising PSA

Summary

In patients with prostate cancer (PC) who have only biochemically relapsed disease after curative treatment (or some locally advanced PC patients), hormonal therapy remains a de facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to androgen withdrawal and to possibly shorten the duration of therapy needed to control the disease.

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) a consensus among investigators on endpoints for studies of patients with a rising PSA, 2) the ability to identify subjects at high risk for developing radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, and 4) the availability of chemotherapy such as docetaxel that can improve survival in subjects with advanced disease.

It is our hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.

This trial will determine whether any benefit is gained by adding chemotherapy to hormonal therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches will be compared in this two-arm randomized clinical trial. The control Arm A provides antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the schematic representation of study design please see Section 7.3.1.

Subjects with a rising PSA following definitive local curative therapy will be eligible, if their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy are eligible, with the same criteria. Subjects with radiographic metastases will be excluded. The primary endpoint of the trial is progression-free survival of subjects that do not experience biochemical failure at 60 months from the start of therapy.

Based on the yearly number of prostate cancer patients who undergo definitive local therapies and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the Scandinavian countries are potential candidates for this approach.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

349

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Copenhagen, Danmark
        • Copenhagen University Hospital, Rigshospitalet
  • Finland
      • Turku, Finland, 20521
        • Turku University Hospital
    • Kuopio Kuopio
      • Kuopio, Kuopio Kuopio, Finland, 70211
        • Kuopio University Hospital
  • Nederland
      • Rotterdam, Nederland, 3015 CE
        • Erasmus Medical Center Rotterdam
  • Sverige
      • Göteborg, Sverige, 41345
        • Sahlgrenska University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Men > 18 and ≤80 years of age.
  • WHO/ECOG performance status 0 - 1 (WHO: World Health Organization; ECOG: Eastern Cooperative Oncology Group )
  • Histological proven adenocarcinoma of the prostate.
  • Patients who are planned to receive antiandrogen (bicalutamide 150 mg x 1) treatment,

  • After curative treatment

    • Prostatectomy: PSA > 10 OR PSA DT < 12 months and PSA > 0.5 (PSA doubling time calculation must start at a minimum value of > 0.5)
    • Radiation: PSA > +2.0 above nadir and PSA >10 OR PSA DT < 12 months and PSA > 0.5. (PSA bouncing after radiotherapy should be excluded according to the local traditions, and PSA doubling time calculation must start at a minimum value of > 0.5)

  • In locally advanced (or local not suitable for curative therapy) prostate cancer patients, PSA < 100 is required before inclusion AND one of the following

    • PSA DT < 12 months or
    • PSA >20 or
    • Gleason score 8-10
  • Previous hormonal therapy in conjunction with radiotherapy is allowed, provided that the total duration of therapy does not exceed 12 months and has to be stopped > 12 months ago.
  • Testosterone value > 5 nmol/l
  • Adequate haematological-, liver- and kidney function. WBC(white blood cell ) 3.5 x 109/L ANC(absolute neutrophil count ) 1.5 x 109/L Platelet Count 150 x 109/L Haemoglobin > 120 g/L Total bilirubin ≤ ULN (upper limit of normal) unless due to Gilbert's disease Creatinine ≤ 1.5 x ULN or creatinine clearance of 60 cc/min or corresponding Iohexol clearance value ASAT(aspartate aminotransferase )/ALAT(alanine aminotransferase) ≤ 1.5 x ULN ALP (Alkaline phosphatase) < 1.5 x ULN
  • Negative bone scan performed no more than 3 months prior to randomisation.
  • Additional CT or ultrasound of thorax, abdomen and/or pelvis is optional.
  • Written informed consent.

Exclusion Criteria:

  • Positive bone scan
  • Any distant metastasis detected by CT or ultrasound
  • Patients with a history of previous malignant disease. Exceptions should be made for basal cell carcinoma (BCC) and squamous cell carcinoma of the skin. Exceptions should also be made for curatively treated malignant disease, which has been disease free for the past 5 years.
  • Previous chemotherapy or randomised in SPCG 12/AdPro or SPCG 13/AdRad (SPCG: Scandinavian Prostate Cancer Group).
  • Systemic corticosteroids within 6 months prior to randomisation.
  • Unstable cardiovascular disease, including myocardial infarction, within 6 months prior to randomisation.
  • Active untreated infectious disease, including tuberculosis, MRSA (Methicillin-resistant Staphylococcus aureus.
  • Active gastric ulcer.
  • Known hypersensitivity to Polysorbate 80 (an excipient of docetaxel)
  • Other serious illness or medical condition
  • Symptomatic peripheral neuropathy ≥ CTCAE grade 2.
  • Patients who by altered physical or psychological state not are able to co-operate or participate in the trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Antiandrogen
Antiandrogen (bicalutamide 150 mg x 1) p.o. alone,
Legemiddel: Antiandrogen
Eksperimentell: Antiandrogen + docetaxel
Antiandrogen (bicalutamide 150 mg x 1) p.o. + Docetaxel 75 mg/m2 (maximum 2.0 m2 ) i.v. q 3 weeks x up to 8-10 cycles.
Legemiddel: Antiandrogen+docetaxel

Antiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2 (max 2.0m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Docetaxel will be given for up to 8-10 cycles or until unacceptable toxicity or consent withdrawal whichever comes first.

Antiemetic therapy may be used if necessary.

Andre navn:
  • Taxotere

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression free survival
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 60 months

Progression free survival defined as the time from randomization to the date of first documentation of:

  • PSA progression PSA progression is considered to occur when PSA is +2.0 ng/ml above nadir. A confirmatory PSA must be taken no less than 6 weeks following the first rising PSA above nadir +2.0 ng/ml. If that confirmatory PSA also exceeds the above parameters, then progression has occurred. If the confirmatory PSA fails to confirm progression, then the patient will remain on study.
  • Radiographic progression Outcome in patients who develop radiographically metastatic disease while on study will be defined as progression independent of their respective PSA values.

These patients will be followed for evaluation of survival.

- Death Death due to prostate cancer in the absence of previous documentation of disease progression,
From date of randomization until the date of first documented progression or date of death from any cause, which ever came first, assessed up to 60 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference between groups in PSA doubling time (PSADT).
Tidsramme: From date of randomization until the date of first documented PSADT, assessed up to 60 months
The PSADT can be calculated by the natural log of 2 (0.693) divided by the slope of the relation between the log of PSA and the time of PSA measurement.
From date of randomization until the date of first documented PSADT, assessed up to 60 months
Difference between groups regarding QoL
Tidsramme: At date of randomization and yearly, assessed up to 60 months
The quality of life (QoL) will be assessed using the FACT-P-T disease-specific subscale. The scoring will be in accordance with version 4 of the FACT manual.
At date of randomization and yearly, assessed up to 60 months
Difference between groups regarding metastasis free survival
Tidsramme: From date of randomization until the date of first documented date of metastases, assessed yearly by bone-scan after first PSA_progression until first sign of metastasis, whichever came first, assessed up to 100 months
Metastasis free survival will be assessed yearly by bone-scan after first PSA progression until the date of first documented metastasis on bone scan, date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented date of metastases, assessed yearly by bone-scan after first PSA_progression until first sign of metastasis, whichever came first, assessed up to 100 months
Difference between groups regarding overall survival
Tidsramme: From date of randomization until the date of death from any cause reported yearly by the study sites up to 100 months
Survival will be assessed yearly up to 100 months after inclusion
From date of randomization until the date of death from any cause reported yearly by the study sites up to 100 months
Difference between groups regarding cancer specific survival
Tidsramme: From date of randomization until date of death from prostate cancer,reported yearly by the study sites up to 100 months
Cancer specific survival will be assessed yearly up to 100 months after inclusion
From date of randomization until date of death from prostate cancer,reported yearly by the study sites up to 100 months
Measurement of grade of toxicity of given treatments
Tidsramme: At date of randomization, during treatment and follow up questionaries until 60 months
Adverse events recording using NCI-CTCAE (v3.0)
At date of randomization, during treatment and follow up questionaries until 60 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Göteborg University

Samarbeidspartnere

Sahlgrenska University Hospital, Västra götalands regionen (Huvudman)

Etterforskere

  • Hovedetterforsker: Andreas Josefsson, PhD, Univeristy of Gothenburg
  • Hovedetterforsker: Ingela Turesson, Prof, Uppsala University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2009

Primær fullføring (Forventet)

1. april 2023

Studiet fullført (Forventet)

1. april 2023

Datoer for studieregistrering

Først innsendt

14. mai 2016

Først innsendt som oppfylte QC-kriteriene

13. april 2017

Først lagt ut (Faktiske)

19. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • version 1.6

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