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Trial · Interventional

Status unknownPhase 4Registry data

FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

NCTNCT00293670 (opens ClinicalTrials.gov in a new tab)Other id9393FN/0001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
573 participants
Sponsor
Tampere University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Finland

Start
May 1997
Primary completion
Not stated
Completion
Apr 2015
First posted
17 Feb 2006 (estimated)
Last update posted
17 Feb 2006 (estimated)
Conditions
Patients With T1-4 Advanced Prostate Cancer

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2000200520102015
  1. Ph 4

    FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

    NCT00293670

    May 1997 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)

Interventions

  • Goserelin (Zoladex)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time To Progression (TTP)

Secondary outcomes(1)

  1. Overall and prostate cancer-specific survival, time to treatment failure, quality of life

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2013

Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects.

Salonen et al. 2013European urologycited by 53

PMID 22857983DOI 10.1016/j.eururo.2012.07.040PUB-22857983

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSalonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. The FinnProstate Study VII: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer. J Urol. 2012 Jun;187(6):2074-81. doi: 10.1016/j.juro.2012.01.122. Epub 2012 Apr 11. PMID 22498230

Eligibility

Who could join, as posted.

Sex
Male
Age
from 0 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA \> 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA \> 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent • Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to \< 10 ng/mL. If the baseline was \< 20ng/mL, at least 50% decrease from the baseline measurement is required Exclusion Criteria (run-in period): Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status \-

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