Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01558427 |
Recruitment Status :
Completed
First Posted : March 20, 2012
Last Update Posted : September 5, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Procedure: Surveillance Procedure: Salvage treatment | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial |
Actual Study Start Date : | August 1, 2012 |
Actual Primary Completion Date : | August 15, 2018 |
Actual Study Completion Date : | August 15, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Active clinical surveillance
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
|
Procedure: Surveillance
Active clinical surveillance |
Experimental: Salvage treatment of metastases
Surgical or radiotherapy treatment of metastases.
|
Procedure: Salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases. |
- Androgen deprivation therapy free survival. [ Time Frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years. ]Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.
- Quality of life questionnaire 1. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)
- Quality of Life questionnaire 2. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]Questionnaire: Short Form (36) Health Survey (SF36)
- Quality of life questionnaire 3 [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]Questionnaire: EORTC QLQ PR25
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558427
Belgium | |
Ghent University Hospital | |
Ghent, Belgium |
Principal Investigator: | Gert De Meerleer, PhD, MD | University Hospital, Ghent |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT01558427 |
Other Study ID Numbers: |
2012/156 |
First Posted: | March 20, 2012 Key Record Dates |
Last Update Posted: | September 5, 2023 |
Last Verified: | September 2023 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |