Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Chronic Disease

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Chronic Graft Versus Host Disease

Closely watching, waiting and treating symptoms if and when cancer progresses

Radical prostatectomy

Timothy J. Wilt, MD MPH

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.

Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.

Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.

Primary Outcomes: All cause mortality.

Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer

Agency for Healthcare Research and Quality (AHRQ)

National Cancer Institute (NCI)

VA Office of Research and Development

Radical Prostatectomy

Watchful Waiting

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Timothy Wilt, MD

Surgical removal of the prostate

Radical prostatectomy: Surgical removal of the prostate

All Cause Mortality

Overall Study

Infections

Virus Diseases

Papilloma

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Immediate Treatment - LEEP - Loop electrosurgical excision procedure

1. loop electrosurgical excision procedure

loop electrosurgical excision procedure (LEEP)

Laurie Elit, MD

Mark Levine, MD

Jim Julian, MMath

This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.

In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).

Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1

Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

Canadian Institutes of Health Research (CIHR)

Ontario Clinical Oncology Group (OCOG)

Dr. Mark Levine

Squamous Intraepithelial Lesions of the Cervix

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with observation and evaluation at 6 and 12 months after diagnosis.

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that were managed with an ablative treatment and evaluated at 6 and 12 months after diagnosis.

Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.

Ablative treatment

Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.

Expectant management

Osvaldo Reyes, MD

To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.

Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.

Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.

Saint Thomas Hospital, Panama

Coordinator of Research

Uterine Cervical Neoplasms

Disease Progression

Patients diagnosed of CIN-II by directed biopsy

Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery

Conservative management

Gemma Mancebo, PhD

Ramon Carreras, PhD

The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors.

Cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN), represents a significant public health problem,induced by persistent infection of human papillomavirus (HPV). It is known that a significant percentage of CIN regresses spontaneously and only a minority of these lesions progress to cervical cancer. CIN-II is an intermediate state that can regress to CIN-I or less, or progress to CIN-III spontaneously. The rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. Overestimating CIN-II lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications.

Patients newly diagnosed with CIN-II colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and NK receptors expression were analyzed in all CIN-II biopsies. Total regression, partial regression, persistence and progression rates of CIN-II were defined as a final outcome.

Citologies and biopsies of the cervix. Blood cells.

p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management

Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2

Cervical cytology test and colposcopy every 4 months starting with diagnose CIN-II or CIN-III means presence of lesion, CIN-I is regression of the lesion, and Negative is abscence of lesion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Cancer Intervention Versus Observation Trial (PIVOT)	NCT00007644	Prostate Cancer	Radical prostat...	- 75 Years	VA Office of Research and Development
Prostate Cancer Intervention Versus Observation Trial (PIVOT)	NCT00007644	Prostate Cancer	Radical prostat...	- 75 Years	VA Office of Research and Development
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1	NCT00156026	Cervical Intrae...	loop electrosur...	16 Years -	Ontario Clinical Oncology Group (OCOG)
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.	NCT02331550	LSIL, Low-Grade...	Ablative treatm... Expectant manag...	-	Saint Thomas Hospital, Panama
p16 and Ki-67 Stainings and Natural Killer (NK) Cells in CIN-II Management	NCT02522585	Cervical Cancer	Conservative ma...	18 Years -	Parc de Salut Mar
Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.	NCT02331550	LSIL, Low-Grade...	Ablative treatm... Expectant manag...	-	Saint Thomas Hospital, Panama

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