trialsTrialCompleted

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

A phase 3 trial of Bicalutamide, Estramustine, Etoposide, Flutamide and Paclitaxel / nab-paclitaxel in Prostate cancer, run by Radiation Therapy Oncology Group, completed.

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00004054 by Radiation Therapy Oncology Group, with 397 participants recorded, started 2000-01 and reaching its primary completion in 2010-04. Interventions recorded: bicalutamide, estramustine phosphate sodium, etoposide, flutamide, paclitaxel, Luteinizing hormone releasing hormone [LHRH] agonist, Radiation therapy, warfarin. Conditions recorded: Prostate Cancer.

Linked to the drug Estramustine because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.

Setting

A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer

Phase

Phase 3

Sponsor

Radiation Therapy Oncology Group

Registry

Started

2000-01

Reported

2015

Enrolled

397 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

397 enrolled

Overall Survival (5-year Rate Reported)primarysurvival endpoint

84.9 vs 87.2 out of 100 alive at 5 years with Hormones and RT compared with Hormones and RT Plus Chemotherapy; 2.3 fewer per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 4 percent higher chance of the event at any given time (hazard ratio 1.04, likely range 0.76 to 1.43).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
These results apply to the people the trial enrolled: A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

397 enrolled.

Overall Survival (5-year Rate Reported)primary

HR 1.04 (0.76 to 1.43) · p = 0.81

Hormones and RT84.9 of 100

n = 197

Hormones and RT Plus Chemotherapy87.2 of 100

n = 200

Download

95% CI 79.9 to 90; Figures from the ClinicalTrials.gov results section (first posted 2015-01-07), not from a publication · 95% CI 82.4 to 91.9

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall Survival (5-year Rate Reported)primary	Hormones and RT	197	84.9%	1.04 (0.76 to 1.43)	0.81	link
Overall Survival (5-year Rate Reported)primary	Hormones and RT Plus Chemotherapy	200	87.2%	1.04 (0.76 to 1.43)	0.81	link

Connected

Similar pages

Trial
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
Shares Flutamide, Bicalutamide, NRG Oncology, Prostate cancer and the tag pipeline.
Trial
Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
Shares Estramustine, Bicalutamide, Prostate cancer and the tag pipeline.
Trial
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
Shares Flutamide, Bicalutamide, NRG Oncology, Localised prostate cancer, high and very high risk and the tag pipeline.
Trial
Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
Shares NRG Oncology, Localised prostate cancer, high and very high risk, Prostate cancer and the tag pipeline.
Trial
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Shares Bicalutamide, Localised prostate cancer, high and very high risk, Prostate cancer and the tag pipeline.
Trial
Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
Shares Flutamide, Bicalutamide, NRG Oncology, Prostate cancer and the tag pipeline.
Trial
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Shares Flutamide, Bicalutamide, Localised prostate cancer, high and very high risk, Prostate cancer and the tag pipeline.
Trial
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
Shares Flutamide, Bicalutamide, Prostate cancer and the tag pipeline.

cancers

Localised prostate cancer, high and very high risk Prostate cancer

drugs

ApprovedOral first-generation non-steroidal antiandrogen

Bicalutamide · Casodex

EstablishedOral oestradiol and nitrogen mustard conjugate

Estramustine · Emcyt

ApprovedTopoisomerase II inhibitor (podophyllotoxin derivative)

Etoposide · VePesid / Etopophos / Toposar

ApprovedNon-steroidal antiandrogen (first generation)

Flutamide · Eulexin (historic)

ApprovedCytotoxic chemotherapy (taxane)

Paclitaxel / nab-paclitaxel · Taxol / Abraxane

companies