Trial Outcomes & Findings for Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer (NCT NCT00288080)

Last Updated: 2022-06-21

Results Overview

Four-year rates are shown. Survival time is defined as time from randomization to 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

612 participants

Primary outcome timeframe

From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Results posted on

2022-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Androgen Suppression + Radiation Therapy (RT) Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Study STARTED	307	305
Overall Study COMPLETED	281	282
Overall Study NOT COMPLETED	26	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Androgen Suppression + Radiation Therapy (RT) Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	25	20

Baseline Characteristics

Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.	Total n=563 Participants Total of all reporting groups
Age, Continuous	66 years n=93 Participants	66 years n=4 Participants	66 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	281 Participants n=93 Participants	282 Participants n=4 Participants	563 Participants n=27 Participants

PRIMARY outcome

Timeframe: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Eligible patients who did not withdraw consent.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Survival	88.7 percentage of participants Interval 84.3 to 91.9	93.3 percentage of participants Interval 89.6 to 95.7

SECONDARY outcome

Timeframe: From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Eligible patients who did not withdraw consent.

Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Biochemical Control	82.0 percentage of participants Interval 76.7 to 86.1	84.1 percentage of participants Interval 79.0 to 88.0

SECONDARY outcome

Timeframe: From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Eligible patients who did not withdraw consent

Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Local Control	99.2 percentage of participants Interval 97.0 to 99.8	99.5 percentage of participants Interval 96.6 to 99.9

SECONDARY outcome

Timeframe: From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Eligible patients who did not withdraw consent.

Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Distant Metastasis	2.6 percentage of participants Interval 1.1 to 5.0	1.9 percentage of participants Interval 0.7 to 4.1

SECONDARY outcome

Timeframe: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Eligible patients who did not withdraw consent.

A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Disease-free Survival	73.0 percentage of participants Interval 67.4 to 77.9	78.5 percentage of participants Interval 73.1 to 82.9

SECONDARY outcome

Timeframe: From start of treatment until the end of follow-up

Population: Eligible patients who started protocol treatment and did not withdraw consent

Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.

Outcome measures

Outcome measures
Measure	Androgen Suppression + Radiation Therapy n=281 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=282 Participants Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Incidence of Adverse Events Grade 1	14.9 percentage of participants	2.1 percentage of participants
Incidence of Adverse Events Grade 2	48.4 percentage of participants	25.9 percentage of participants
Incidence of Adverse Events Grade 3	26.0 percentage of participants	40.1 percentage of participants
Incidence of Adverse Events Grade 4	4.3 percentage of participants	28.4 percentage of participants
Incidence of Adverse Events Grade 5	1.4 percentage of participants	0.7 percentage of participants

SECONDARY outcome

Timeframe: From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years.

Population: The analysis will not be done because testosterone measurement dates were not collected.

Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Population: Because the second criterion is not met, further analysis was not performed.

Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint): 1. Treatment is prognostic for true endpoint 2. Treatment is prognostic for surrogate endpoint 3. Surrogate is prognostic for true endpoint 4. The full effect of the treatment on the true endpoint is explained by the surrogate. If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated.

Outcome measures

Outcome data not reported

Adverse Events

Androgen Suppression + Radiation Therapy

Serious events: 26 serious events

Other events: 278 other events

Deaths: 0 deaths

Androgen Suppression + Radiation Therapy + Chemotherapy

Serious events: 93 serious events

Other events: 289 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Androgen Suppression + Radiation Therapy n=302 participants at risk Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=302 participants at risk Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/302 Participants who started protocol treatment.	4.0% 12/302 Participants who started protocol treatment.
Blood and lymphatic system disorders Hemoglobin	0.00% 0/302 Participants who started protocol treatment.	3.3% 10/302 Participants who started protocol treatment.
Cardiac disorders Angina pectoris	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/302 Participants who started protocol treatment.	0.99% 3/302 Participants who started protocol treatment.
Cardiac disorders Cardiac general - Other	0.33% 1/302 Participants who started protocol treatment.	0.99% 3/302 Participants who started protocol treatment.
Cardiac disorders Myocardial ischemia	2.0% 6/302 Participants who started protocol treatment.	1.7% 5/302 Participants who started protocol treatment.
Cardiac disorders Myocarditis NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Cardiac disorders Ventricular arrhythmia NOS	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Gastrointestinal disorders Abdominal pain NOS	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Gastrointestinal disorders Colitis NOS	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Colonic perforation	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Diarrhea NOS	0.33% 1/302 Participants who started protocol treatment.	3.0% 9/302 Participants who started protocol treatment.
Gastrointestinal disorders Gastritis NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Gastrointestinal - Other	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Ileus paralytic	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Nausea	0.33% 1/302 Participants who started protocol treatment.	0.99% 3/302 Participants who started protocol treatment.
Gastrointestinal disorders Pancreatitis NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Gastrointestinal disorders Vomiting NOS	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
General disorders Chest pain	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
General disorders Edema: limb	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
General disorders Fatigue	0.00% 0/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
General disorders Multi-organ failure	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
General disorders Pyrexia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
General disorders Sudden death	0.99% 3/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
General disorders Syndromes - Other	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Immune system disorders Hypersensitivity NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Bladder infection NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Infection - Other	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis)	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Blood	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Infection with unknown ANC: Skin (cellulitis)	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Kidney infection NOS	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Infections and infestations Lymph gland infection	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Infections and infestations Pneumonia NOS	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Infections and infestations Urinary tract infection NOS	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Injury, poisoning and procedural complications Dermatitis radiation NOS	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Injury, poisoning and procedural complications Fracture NOS	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Injury, poisoning and procedural complications Vascular access NOS complication	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Investigations Blood creatinine increased	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Investigations Hypercholesterolemia	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Investigations Leukopenia NOS	0.00% 0/302 Participants who started protocol treatment.	7.9% 24/302 Participants who started protocol treatment.
Investigations Lymphopenia	0.00% 0/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
Investigations Metabolic/laboratory - Other	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Investigations Neutrophil count	0.00% 0/302 Participants who started protocol treatment.	11.3% 34/302 Participants who started protocol treatment.
Investigations Platelet count decreased	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Investigations Troponin I increased	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Investigations Weight decreased	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Dehydration	0.33% 1/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hyperglycemia NOS	0.00% 0/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - Other	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Nervous system disorders Cerebral ischemia	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Nervous system disorders Dizziness	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Nervous system disorders Neurology - Other	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Nervous system disorders Peripheral motor neuropathy	0.33% 1/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Nervous system disorders Syncope	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Psychiatric disorders Depression	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Psychiatric disorders Euphoric mood	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Psychiatric disorders Insomnia	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Psychiatric disorders Libido decreased	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Renal and urinary disorders Cystitis NOS	0.33% 1/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Renal and urinary disorders Pollakiuria	0.33% 1/302 Participants who started protocol treatment.	0.99% 3/302 Participants who started protocol treatment.
Renal and urinary disorders Renal failure NOS	0.33% 1/302 Participants who started protocol treatment.	0.99% 3/302 Participants who started protocol treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Renal and urinary disorders Urinary retention	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Reproductive system and breast disorders Ejaculatory disorder NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Reproductive system and breast disorders Erectile dysfunction NOS	0.00% 0/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.99% 3/302 Participants who started protocol treatment.	1.3% 4/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	0.33% 1/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - Other	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Dermatology/skin - Other	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Localised exfoliation	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Sweating increased	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Vascular disorders Hot flushes NOS	0.66% 2/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Vascular disorders Hypertension NOS	0.00% 0/302 Participants who started protocol treatment.	0.33% 1/302 Participants who started protocol treatment.
Vascular disorders Hypotension NOS	0.33% 1/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.
Vascular disorders Peripheral ischemia	0.33% 1/302 Participants who started protocol treatment.	0.00% 0/302 Participants who started protocol treatment.
Vascular disorders Thrombosis	0.00% 0/302 Participants who started protocol treatment.	0.66% 2/302 Participants who started protocol treatment.

Measure	Androgen Suppression + Radiation Therapy n=302 participants at risk Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.	Androgen Suppression + Radiation Therapy + Chemotherapy n=302 participants at risk Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Blood and lymphatic system disorders Blood/bone marrow - Other	0.99% 3/302 Participants who started protocol treatment.	6.0% 18/302 Participants who started protocol treatment.
Blood and lymphatic system disorders Hemoglobin	12.3% 37/302 Participants who started protocol treatment.	58.3% 176/302 Participants who started protocol treatment.
Eye disorders Lacrimation increased	0.66% 2/302 Participants who started protocol treatment.	5.3% 16/302 Participants who started protocol treatment.
Gastrointestinal disorders Abdominal pain NOS	5.0% 15/302 Participants who started protocol treatment.	7.6% 23/302 Participants who started protocol treatment.
Gastrointestinal disorders Constipation	9.6% 29/302 Participants who started protocol treatment.	17.9% 54/302 Participants who started protocol treatment.
Gastrointestinal disorders Diarrhea NOS	50.7% 153/302 Participants who started protocol treatment.	52.6% 159/302 Participants who started protocol treatment.
Gastrointestinal disorders Dyspepsia	2.0% 6/302 Participants who started protocol treatment.	8.3% 25/302 Participants who started protocol treatment.
Gastrointestinal disorders Fecal incontinence	5.3% 16/302 Participants who started protocol treatment.	4.3% 13/302 Participants who started protocol treatment.
Gastrointestinal disorders Gastrointestinal - Other	6.6% 20/302 Participants who started protocol treatment.	8.3% 25/302 Participants who started protocol treatment.
Gastrointestinal disorders Hemorrhoids	5.0% 15/302 Participants who started protocol treatment.	4.3% 13/302 Participants who started protocol treatment.
Gastrointestinal disorders Nausea	4.3% 13/302 Participants who started protocol treatment.	26.8% 81/302 Participants who started protocol treatment.
Gastrointestinal disorders Proctitis NOS	14.2% 43/302 Participants who started protocol treatment.	15.6% 47/302 Participants who started protocol treatment.
Gastrointestinal disorders Rectal hemorrhage	12.3% 37/302 Participants who started protocol treatment.	13.6% 41/302 Participants who started protocol treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/302 Participants who started protocol treatment.	9.6% 29/302 Participants who started protocol treatment.
Gastrointestinal disorders Vomiting NOS	2.6% 8/302 Participants who started protocol treatment.	6.0% 18/302 Participants who started protocol treatment.
General disorders Edema: limb	5.0% 15/302 Participants who started protocol treatment.	16.9% 51/302 Participants who started protocol treatment.
General disorders Fatigue	52.0% 157/302 Participants who started protocol treatment.	77.8% 235/302 Participants who started protocol treatment.
General disorders Pain - Other	5.3% 16/302 Participants who started protocol treatment.	8.6% 26/302 Participants who started protocol treatment.
Investigations Alanine aminotransferase increased	5.3% 16/302 Participants who started protocol treatment.	10.3% 31/302 Participants who started protocol treatment.
Investigations Aspartate aminotransferase increased	5.6% 17/302 Participants who started protocol treatment.	7.6% 23/302 Participants who started protocol treatment.
Investigations Blood alkaline phosphatase increased	2.3% 7/302 Participants who started protocol treatment.	5.0% 15/302 Participants who started protocol treatment.
Investigations Leukopenia NOS	6.6% 20/302 Participants who started protocol treatment.	48.0% 145/302 Participants who started protocol treatment.
Investigations Lymphopenia	7.9% 24/302 Participants who started protocol treatment.	20.9% 63/302 Participants who started protocol treatment.
Investigations Metabolic/laboratory - Other	1.3% 4/302 Participants who started protocol treatment.	8.3% 25/302 Participants who started protocol treatment.
Investigations Neutrophil count	0.99% 3/302 Participants who started protocol treatment.	35.4% 107/302 Participants who started protocol treatment.
Investigations Platelet count decreased	3.6% 11/302 Participants who started protocol treatment.	11.3% 34/302 Participants who started protocol treatment.
Investigations Weight decreased	2.0% 6/302 Participants who started protocol treatment.	5.6% 17/302 Participants who started protocol treatment.
Investigations Weight increased	7.0% 21/302 Participants who started protocol treatment.	13.2% 40/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Anorexia	2.3% 7/302 Participants who started protocol treatment.	10.9% 33/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hyperglycemia NOS	5.3% 16/302 Participants who started protocol treatment.	34.1% 103/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hypoalbuminemia	1.7% 5/302 Participants who started protocol treatment.	10.6% 32/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hypokalemia	0.66% 2/302 Participants who started protocol treatment.	5.3% 16/302 Participants who started protocol treatment.
Metabolism and nutrition disorders Hyponatremia	0.99% 3/302 Participants who started protocol treatment.	9.3% 28/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 25/302 Participants who started protocol treatment.	21.2% 64/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Back pain	8.3% 25/302 Participants who started protocol treatment.	14.2% 43/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Bone pain	3.0% 9/302 Participants who started protocol treatment.	6.0% 18/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	5.3% 16/302 Participants who started protocol treatment.	7.6% 23/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - Other	2.3% 7/302 Participants who started protocol treatment.	5.6% 17/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Myalgia	3.3% 10/302 Participants who started protocol treatment.	11.9% 36/302 Participants who started protocol treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 10/302 Participants who started protocol treatment.	9.6% 29/302 Participants who started protocol treatment.
Nervous system disorders Dizziness	2.6% 8/302 Participants who started protocol treatment.	9.6% 29/302 Participants who started protocol treatment.
Nervous system disorders Dysgeusia	0.66% 2/302 Participants who started protocol treatment.	17.5% 53/302 Participants who started protocol treatment.
Nervous system disorders Peripheral motor neuropathy	2.0% 6/302 Participants who started protocol treatment.	6.3% 19/302 Participants who started protocol treatment.
Nervous system disorders Peripheral sensory neuropathy	6.6% 20/302 Participants who started protocol treatment.	36.4% 110/302 Participants who started protocol treatment.
Psychiatric disorders Anxiety	2.3% 7/302 Participants who started protocol treatment.	5.0% 15/302 Participants who started protocol treatment.
Psychiatric disorders Depression	6.6% 20/302 Participants who started protocol treatment.	6.6% 20/302 Participants who started protocol treatment.
Psychiatric disorders Insomnia	7.3% 22/302 Participants who started protocol treatment.	17.5% 53/302 Participants who started protocol treatment.
Psychiatric disorders Libido decreased	21.5% 65/302 Participants who started protocol treatment.	20.9% 63/302 Participants who started protocol treatment.
Renal and urinary disorders Bladder pain	2.0% 6/302 Participants who started protocol treatment.	6.0% 18/302 Participants who started protocol treatment.
Renal and urinary disorders Cystitis NOS	10.9% 33/302 Participants who started protocol treatment.	15.2% 46/302 Participants who started protocol treatment.
Renal and urinary disorders Pollakiuria	69.2% 209/302 Participants who started protocol treatment.	69.5% 210/302 Participants who started protocol treatment.
Renal and urinary disorders Renal/genitourinary - Other	12.9% 39/302 Participants who started protocol treatment.	15.6% 47/302 Participants who started protocol treatment.
Renal and urinary disorders Urinary incontinence	11.3% 34/302 Participants who started protocol treatment.	15.6% 47/302 Participants who started protocol treatment.
Renal and urinary disorders Urinary retention	18.2% 55/302 Participants who started protocol treatment.	18.5% 56/302 Participants who started protocol treatment.
Renal and urinary disorders Urogenital hemorrhage	3.3% 10/302 Participants who started protocol treatment.	5.0% 15/302 Participants who started protocol treatment.
Reproductive system and breast disorders Ejaculatory disorder NOS	7.3% 22/302 Participants who started protocol treatment.	7.9% 24/302 Participants who started protocol treatment.
Reproductive system and breast disorders Erectile dysfunction NOS	40.4% 122/302 Participants who started protocol treatment.	39.7% 120/302 Participants who started protocol treatment.
Reproductive system and breast disorders Gynecomastia	6.6% 20/302 Participants who started protocol treatment.	8.3% 25/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.0% 12/302 Participants who started protocol treatment.	13.6% 41/302 Participants who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.9% 27/302 Participants who started protocol treatment.	22.5% 68/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Alopecia	2.3% 7/302 Participants who started protocol treatment.	39.4% 119/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	2.3% 7/302 Participants who started protocol treatment.	9.3% 28/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Dermatology/skin - Other	4.3% 13/302 Participants who started protocol treatment.	7.9% 24/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Dry skin	0.99% 3/302 Participants who started protocol treatment.	6.0% 18/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Nail disorder NOS	0.33% 1/302 Participants who started protocol treatment.	16.9% 51/302 Participants who started protocol treatment.
Skin and subcutaneous tissue disorders Sweating increased	4.6% 14/302 Participants who started protocol treatment.	7.3% 22/302 Participants who started protocol treatment.
Vascular disorders Hot flushes NOS	68.2% 206/302 Participants who started protocol treatment.	63.6% 192/302 Participants who started protocol treatment.
Vascular disorders Hypertension NOS	2.6% 8/302 Participants who started protocol treatment.	5.0% 15/302 Participants who started protocol treatment.