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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

NCTNCT00586898 (opens ClinicalTrials.gov in a new tab)Other id01-085
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
36 participants (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2001
Primary completion
Mar 2009
Completion
Mar 2009
First posted
7 Jan 2008 (estimated)
Last update posted
25 Mar 2016 (estimated)
Conditions
Prostate · Cancer · Hormonal Cycling

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022004200620082010
  1. Ph 2

    Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

    NCT00586898

    Jul 2001 to Mar 2009

Registry summary

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

Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.

Interventions

  • GnRHDrug
  • KetoconazoleDrug
  • BicalutamideDrug
  • Testosterone transdermal gelDrug
  • Estrogen transdermal patchDrug

Arms1

  • Experimental

    1

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Response

    Time frame · 6 months

    Registry description

    Complete Response: Normalization of the PSA (\< or = to 4.0 for patients with castrate metastatic disease, or \< 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by \> or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.

Posted results

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

Primary outcome results

Primary outcomeNumber· 6 months

Response

GroupValue (participants)
All Participants22

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All ParticipantsRapid Hormonal Cycling as Treatment for Patients with Prostate Cancer–2 / 3620 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: -Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease. B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: \>2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50% * Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC. * Patient must have level of serum testosterone above the lower limit of normal. * Karnofskcy performance status (KPS) \>\_70%. * Patients must have adequate organ function as defined by the following laboratory criteria: * WBC \>\_3500/mm3, platelet count \>\_100,000/mm3. * Bilirubin \<2.0 mg/dl or SGOT \<3.0 X the upper limit of normal. * Creatinine \<\_1.6 mg/dl or creatinine clearance \>\_60 cc/min. * Prior hormonal therapy is allowed as: 1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months. 2. One cycle of intermittent therapy up to a maximum exposure of 10 months. * Patients must be at least 18 years of age. * Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment Exclusion Criteria: * Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease. * Uncontrolled serious active infection. * Anticipated survival of less than 3 months. * Active CNS or epiduraltumor * Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.

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