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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

NCTNCT00528866 (opens ClinicalTrials.gov in a new tab)Other idRTOG-0621Other idCDR0000563917Other idNCI-2009-00740
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the summary.
  • Names Leuprolide, does not test it. It appears in the summary.
  • Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
80 participants (actual)
Sponsor
Radiation Therapy Oncology Group · Network
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Apr 2008
Primary completion
Dec 2013
Completion
14 May 2018
First posted
12 Sept 2007 (estimated)
Last update posted
24 Apr 2019
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820102012201420162018
  1. Ph 2

    Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

    NCT00528866

    Apr 2008 to 14 May 2018

Registry summary

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

RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.

Interventions

  • bicalutamideDrug
  • docetaxelDrug
  • flutamideDrug
  • LHRH agonistDrug
  • 3-dimensional conformal radiation therapyRadiation
  • radiation therapyRadiation

Arms1

  • Experimental

    Androgen suppression + RT + docetaxel

    LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Free From Progression at 3 Years

    Time frame · From registration to 3 years.

    Registry description

    Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.

Secondary outcomes(9)

  1. Local-regional Progression (3 Year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.

  2. Distant Metastasis (3-year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.

  3. Prostate Cancer Death (3-year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.

  4. Non-prostate Cancer Death (3-year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.

  5. Overall Survival (3-year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.

  6. Time to Biochemical (PSA) Failure (3-year Rate)

    Time frame · Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.

  7. Number of Patients With "Acute" Adverse Events (Based on CTCAE, v3.0)

    Time frame · From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.

    Registry description

    The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

  8. Time to "Late" Grade 3+ Adverse Events (Based on CTCAE, v3.0)

    Time frame · From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)

    Registry description

    Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

  9. Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints

    Time frame · Analysis can occur at the same time as the primary endpoint if data is available.

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· From registration to 3 years.

Number of Participants Free From Progression at 3 Years

GroupValue (participants)
Androgen Suppression + RT + Docetaxel54
Secondary and other outcome results(7)
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Local-regional Progression (3 Year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel0
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Distant Metastasis (3-year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel6.8
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Prostate Cancer Death (3-year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel0
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Non-prostate Cancer Death (3-year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel1.4
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Overall Survival (3-year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel98.6
Secondary outcomeNumber· Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)

Time to Biochemical (PSA) Failure (3-year Rate)

GroupValue (percentage of participants)
Androgen Suppression + RT + Docetaxel25.7
Secondary outcomeNumber· From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.

Number of Patients With "Acute" Adverse Events (Based on CTCAE, v3.0)

GroupValue (participants)
Androgen Suppression + RT + Docetaxel57

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androgen Suppression + RT + DocetaxelLHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel–20 / 7473 / 74

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
DISEASE CHARACTERISTICS: * Pathologically proven adenocarcinoma of the prostate gland meeting one of the following criteria: * Gleason ≥ 7and post-operative PSA nadir \> 0.2 ng/ml with any pathologic tumor (pT) classification * Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification * Must have undergone radical prostatectomy within the past year * PSA must be obtained within 6 weeks (42 days) prior to study registration * No lymph node or distant metastases (N0, M0), based upon the following minimum diagnostic workup: * History and physical examination within 8 weeks prior to study registration * Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on bone scan within 16 weeks prior to study registration * No pelvic lymph nodes \> 1.5 cm in greatest dimension on CT scan or MRI of the pelvis within 16 weeks prior to study registration, unless the enlarged lymph node is biopsied and negative PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * Absolute neutrophil count (ANC) ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Total bilirubin ≤ 1.2 times ULN * No other invasive malignancy within the past 3 years except non-melanomatous skin cancer * No active, severe co-morbidity, including any of the following: * Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * Transmural myocardial infarction within the past 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy * AIDS * HIV testing is not required for study entry * No prior allergic reaction to the study drug(s) PRIOR CONCURRENT THERAPY: * No prior systemic chemotherapy for prostate cancer * More than 3 years since prior chemotherapy for a different cancer * No prior androgen deprivation for treatment of prostate cancer * Prior use of hormonal agents, such as finasteride or dutasteride, for treatment of benign prostatic hypertrophy is allowed * No prior radiotherapy to the region of the prostate that would result in overlap of radiotherapy fields

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