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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

NCTNCT00005044 (opens ClinicalTrials.gov in a new tab)Other idRTOG-9910Other idCDR0000067635
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,579 participants (actual)
Sponsor
Radiation Therapy Oncology Group · Network
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Feb 2000
Primary completion
Sept 2012
Completion
20 May 2022
First posted
27 Jan 2003 (estimated)
Last update posted
15 Jun 2022
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20002005201020152020
  1. Ph 3

    Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

    NCT00005044

    Feb 2000 to 20 May 2022

Registry summary

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

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Interventions

  • CasodexDrug
  • EulexinDrug
  • LHRH agonistDrug
  • radiation therapyRadiation

Arms2

  • Experimental

    TAS x 8 weeks

    Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).

  • Experimental

    TAS x 28 weeks

    TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Disease-specific Survival (DSS) (10-year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.

Secondary outcomes(6)

  1. Overall Survival (OS) (10-year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.

  2. Disease-free Survival (DFS) (10-year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.

  3. Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.

  4. Time to First Biochemical Failure (BF) (10-year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.

  5. Time to Second Biochemical Failure (SBF) (10-year Rates Reported)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.

  6. Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)

    Time frame · From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

    Registry description

    Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.

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 randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Disease-specific Survival (DSS) (10-year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks95
TAS x 28 Weeks96
Secondary and other outcome results(6)
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Overall Survival (OS) (10-year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks66
TAS x 28 Weeks67
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Disease-free Survival (DFS) (10-year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks24
TAS x 28 Weeks23
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks6
TAS x 28 Weeks4
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Time to First Biochemical Failure (BF) (10-year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks56
TAS x 28 Weeks59
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Time to Second Biochemical Failure (SBF) (10-year Rates Reported)

GroupValue (percentage of participants)
TAS x 8 Weeks10
TAS x 28 Weeks9
Secondary outcomeNumber· From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)

Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)

GroupValue (percentage of participants)
TAS x 8 Weeks30.8
TAS x 28 Weeks19.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TAS x 8 WeeksTotal Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).–121 / 747695 / 747
TAS x 28 WeeksTAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).–109 / 735707 / 735

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.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPisansky TM, Hunt D, Gomella LG, Amin MB, Balogh AG, Chinn DM, Seider MJ, Duclos M, Rosenthal SA, Bauman GS, Gore EM, Rotman MZ, Lukka HR, Shipley WU, Dignam JJ, Sandler HM. Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910. J Clin Oncol. 2015 Feb 1;33(4):332-9. doi: 10.1200/JCO.2014.58.0662. Epub 2014 Dec 22. PMID 25534388
  • DerivedSpratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29. PMID 38320143

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 120 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria 1. Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date. 2. Zubrod Performance Status 0-1 (Appendix II). 3. Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization. 4. Patients at intermediate risk for disease relapse as determined by any of the following combinations of factors (NOTE: tumor found in one or both lobes on biopsy, but not palpable, will not alter T stage): * Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen \>10 but ≤ 100. * Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen \< 20. * Clinical stage T1b-1c, Gleason score 8-10, and prostate-specific antigen \<20. 5. Clinically negative (N0) lymph nodes (LN) as established by imaging (pelvic ± abdominal CT, MRI or LAG), or negative LN by nodal sampling or dissection (laparoscopy or laparotomy). Patients with radiologic (e.g., CT, MRI or LAG) or radioimmunoscintigraphy (i.e., ProstaScint™) findings suggestive of regional nodal involvement are eligible if cytologic (e.g., needle aspiration) or histologic (e.g., surgical sampling) evaluation shows no evidence of a neoplastic process (i.e., prostatic or non-prostatic malignancy). Patients with equivocal radiologic findings (maximum nodal size ≤ 1.5 cm) are eligible. 6. No distant (M0) metastases. Patients with radionuclide imaging (e.g., bone scintigraphy, ProstaScint™) findings suggestive, but not diagnostic of metastatic disease are eligible if radiologic (e.g., standard or tomographic radiography, or CT/MRI) imaging does not confirm metastatic disease. 7. Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc. 8. Treatment must begin within 6 weeks after randomization. 9. Alanine aminotransferase (ALT) must be within 2 x upper normal limit. 10. Patients must sign a study-specific informed consent form (Appendix I) prior to randomization. Exclusion Criteria 1. Patients at high risk for disease relapse as determined by either: * Prostate-specific antigen ≥ 20 and Gleason score ≥ 7 (any T stage). * Clinical stage ≥T2 and Gleason score ≥ 8 (any prostate-specific antigen). 2. Patients at low risk for disease relapse as determined by: • Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10. 3. Clinical stage Tx, T0, or T1a. 4. Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1). 5. Pretherapy serum prostate-specific antigen level \> 100. 6. Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of \<10 years. 7. Any of the following prior therapies: * Pelvic external beam radiation therapy. * Radionuclide prostate brachytherapy. * Prostatectomy or prostatic cryosurgery. * Prior bilateral orchiectomy. * Prior androgen suppression therapy; however, patients begun on LHRH agonist therapy remain eligible if (1) LHRH agonists were started no more than 30 days before randomization, and (2) Casodex or Eulexin was (or will be) started no more than 14 days before or after the date that the LHRH agonist injection was given. Any finasteride therapy administered for prostatic hypertrophy must be discontinued. * Chemotherapy for prostatic carcinoma. 8. Previous or concomitant invasive cancer, other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5 years. 9. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up. 10. The patient's participation in another medical research study that involves prostate cancer treatment.

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