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Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial


Phase 2
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial


Inclusion Criteria:



- Histologically proven diagnosis of prostate cancer (PCa)

- Biochemical relapse of PCa following radical local prostate treatment

- N1 and M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.

- World Health Organization (WHO) performance state 0-1

- Exclusion of local relapse

- Age >=18 years old

- Signed informed consent

Exclusion Criteria:

- Serum testosterone level <50ng/ml

- Symptomatic metastases

- PSA rise while on active treatment with luteinizing hormone-releasing hormone
(LHRH)-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen

- Previous treatment with cytotoxic agent for PCa

- Treatment during the past month with products known to influence Prostate Specific
Antigen (PSA) levels (e.g. fluconazole, finasteride, corticosteroids,…)

- Disorder precluding understanding of trial information or informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Androgen deprivation therapy free survival.

Outcome Description:

Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.

Outcome Time Frame:

From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.

Safety Issue:

No

Principal Investigator

Gert De Meerleer, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ghent University Hospital

Authority:

Belgium: Ethics Committee

Study ID:

2012/156

NCT ID:

NCT01558427

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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