Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

• ClinicalTrials.gov Identifier: NCT00002874
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Results First Posted: August 18, 2017
• Last Update Posted: June 15, 2022
• Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); SWOG Cancer Research Network; NRG Oncology
• Information provided by (Responsible Party): Radiation Therapy Oncology Group

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Prostate Cancer
• Interventions: Drug: bicalutamide; Radiation: radiation therapy; Drug: placebo
• Enrollment: 840

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Bicalutamide	Placebo
Arm/Group Description	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)	Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Period Title: Overall Study
Started	421	419
Completed [1]	376	384
Not Completed	45	35
Reason Not Completed
Withdrawal by Subject	1	1
Protocol Violation	44	34
[1] Subjects with data available for the primary analysis are considered to have completed the study.

Baseline Characteristics

Arm/Group Title		Bicalutamide	Placebo	Total
Arm/Group Description		Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Total of all reporting groups
Overall Number of Baseline Participants		376	384	760
Baseline Analysis Population Description		Eligible patients who have not withdrawn
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	376 participants	384 participants	760 participants
		65; (45 to 81)	65; (40 to 83)	65; (40 to 83)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	376 participants	384 participants	760 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	376 100.0%	384 100.0%	760 100.0%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (12-year Rates Reported)
Description	Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	394	376
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	71.3; (66.5 to 76.0)	76.3; (71.9 to 80.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.020
	Comments	One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.59 to 0.98
	Estimation Comments	Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (< 0.5 vs. >= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.

2. Secondary Outcome

Title	Non-Prostate Cancer Death (12-year Rates Reported)
Description	Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	15.3; (11.8 to 19.3)	17.9; (14.0 to 22.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.289
	Comments	[Not Specified]
	Method	Gray's test
	Comments	One-sided test
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.53
	Estimation Comments	[Not Specified]
Other Statistical Analysis		Reference level = placebo arm

3. Secondary Outcome

Title	Second PSA Recurrence (12-year Rates Reported)
Description	Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to >= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of >= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of >= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	67.9; (62.7 to 72.5)	44.0; (38.8 to 49.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Gray's test
	Comments	One-sided test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; 0.40 to 0.58
	Estimation Comments	Reference level = placebo arm

4. Secondary Outcome

Title	Third PSA Recurrence (12-year Rates Reported)
Description	Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame	From start of salvage hormone therapy to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent and who started salvage hormone therapy.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	167	111
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	80.7; (73.2 to 86.3)	84.2; (75.0 to 90.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.213
	Comments	[Not Specified]
	Method	Gray's test
	Comments	One-sided test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.46
	Estimation Comments	Reference level = placebo arm

5. Secondary Outcome

Title	PSA Complete Response at End of Protocol Treatment
Description	Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA < 05 ng/ml.
Time Frame	End of protocol treatment, which is planned to last for two years

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Count of Participants; Unit of Measure: Participants
	259 68.9%	360 93.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

6. Secondary Outcome

Title	Distant Failure (12-year Rates Reported)
Description	Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	23.0; (18.8 to 27.5)	14.5; (11.1 to 18.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Gray's test
	Comments	One-sided test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.87
	Estimation Comments	Reference level = placebo arm

7. Secondary Outcome

Title	Prostate Cancer Death (12-year Rates Reported)
Description	Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Prostate cancer death" is a more accurate wording for the protocol endpoint of "disease-specific survival", and matches the protocol definition.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	13.4; (10.1 to 17.2)	5.8; (3.6 to 8.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Gray's test
	Comments	One-sided test
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.74
	Estimation Comments	Reference level = placebo arm

8. Secondary Outcome

Title	Progression-free Survival (12-year Rates Reported)
Description	Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.
Time Frame	From date of randomization to 12 years.

Outcome Measure Data

Analysis Population Description

Eligible patients who did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	376	384
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	23.9; (19.4 to 28.4)	38.8; (33.7 to 43.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-side test
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.50 to 0.71
	Estimation Comments	[Not Specified]
Other Statistical Analysis		Reference level = placebo arm

9. Secondary Outcome

Title	Grade 3+ Toxicity
Description	Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.
Time Frame	From date of randomization to four years.

Outcome Measure Data

Analysis Population Description

Eligible patients who started protocol treatment and did not withdraw consent.

Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description:	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Overall Number of Participants Analyzed	374	382
Measure Type: Number; Unit of Measure: participants
Acute radiotherapy toxicity	17	8
Hormone therapy and late radiotherapy toxicity	73	100

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	Acute radiotherapy toxicity
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.060
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Bicalutamide
	Comments	Hormone therapy and late radiotherapy toxicity
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.029
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.
Arm/Group Title	Placebo	Bicalutamide
Arm/Group Description	Radiation therapy (64.8 Gy) + placebo (daily 2 years)	Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
All-Cause Mortality
	Placebo	Bicalutamide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Placebo	Bicalutamide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	84/382 (21.99%)	97/374 (25.94%)
Blood and lymphatic system disorders
Acute RT Toxicity: Hematologic: NOS † 1	3/382 (0.79%)	2/374 (0.53%)
Hematologic: NOS * 2	5/382 (1.31%)	5/374 (1.34%)
Cardiac disorders
Cardiac: NOS * 2	18/382 (4.71%)	6/374 (1.60%)
Gastrointestinal disorders
Acute RT Toxicity: Bowel: NOS † 1	1/382 (0.26%)	3/374 (0.80%)
Bowel/GI: NOS * 2	10/382 (2.62%)	8/374 (2.14%)
Nausea/vomiting: NOS * 2	1/382 (0.26%)	1/374 (0.27%)
General disorders
Acute RT Toxicity: Other: NOS † 1	0/382 (0.00%)	1/374 (0.27%)
Other: NOS * 2	16/382 (4.19%)	16/374 (4.28%)
Pain: NOS * 2	2/382 (0.52%)	6/374 (1.60%)
Hepatobiliary disorders
Liver: NOS * 2	2/382 (0.52%)	1/374 (0.27%)
Nervous system disorders
Neurologic: NOS * 2	8/382 (2.09%)	5/374 (1.34%)
Renal and urinary disorders
Acute RT Toxicity: Bladder: NOS † 1	4/382 (1.05%)	11/374 (2.94%)
Bladder/GU: NOS * 2	28/382 (7.33%)	30/374 (8.02%)
Reproductive system and breast disorders
Impotence: NOS * 2	28/382 (7.33%)	16/374 (4.28%)
Respiratory, thoracic and mediastinal disorders
Dyspnea: NOS * 2	3/382 (0.79%)	1/374 (0.27%)
Skin and subcutaneous tissue disorders
Skin-general: NOS * 2	2/382 (0.52%)	3/374 (0.80%)
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, Coop. Group CTC; 2 Term from vocabulary, RTOG Acute RT Morb.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Bicalutamide
	Affected / at Risk (%)	Affected / at Risk (%)
Total	346/382 (90.58%)	374/374 (100.00%)
Blood and lymphatic system disorders
Acute RT Toxicity: Hematologic: NOS † 1	34/382 (8.90%)	28/374 (7.49%)
Hematologic: NOS * 2	58/382 (15.18%)	36/374 (9.63%)
Cardiac disorders
Cardiac: NOS * 2	21/382 (5.50%)	10/374 (2.67%)
Gastrointestinal disorders
Acute RT Toxicity: Bowel: NOS † 1	232/382 (60.73%)	235/374 (62.83%)
Bowel/GI: NOS * 2	192/382 (50.26%)	168/374 (44.92%)
Nausea/vomiting: NOS * 2	19/382 (4.97%)	12/374 (3.21%)
General disorders
Acute RT Toxicity: Other: NOS † 1	68/382 (17.80%)	50/374 (13.37%)
Other: NOS * 2	129/382 (33.77%)	100/374 (26.74%)
Pain: NOS * 2	54/382 (14.14%)	65/374 (17.38%)
Injury, poisoning and procedural complications
Acute RT Toxicity: Skin: NOS † 1	87/382 (22.77%)	88/374 (23.53%)
Skin-within XRT field: NOS * 2	46/382 (12.04%)	34/374 (9.09%)
Nervous system disorders
Neurologic: NOS * 2	23/382 (6.02%)	26/374 (6.95%)
Renal and urinary disorders
Acute RT Toxicity: Bladder: NOS † 1	188/382 (49.21%)	165/374 (44.12%)
Bladder/GU: NOS * 2	232/382 (60.73%)	222/374 (59.36%)
Reproductive system and breast disorders
Gynecomastia: NOS * 2	266/382 (69.63%)	42/374 (11.23%)
Impotence: NOS * 2	46/382 (12.04%)	37/374 (9.89%)
Skin and subcutaneous tissue disorders
Skin-general: NOS * 2	49/382 (12.83%)	15/374 (4.01%)
Vascular disorders
Hot flashes: NOS * 2	83/382 (21.73%)	67/374 (17.91%)
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, Coop. Group CTC; 2 Term from vocabulary, RTOG Acute RT Morb.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology
• EMail: seiferheldw@nrgoncology.org

Publications of Results:

Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Modonutti D, Majdalany SE, Corsi N, Li P, Sood A, Dalela D, Jamil ML, Hwang C, Menon M, Rogers CG, Trinh QD, Novara G, Abdollah F. A novel prognostic model predicting overall survival in patients with metastatic castration-resistant prostate cancer receiving standard chemotherapy: A multi-trial cohort analysis. Prostate. 2022 Sep;82(13):1293-1303. doi: 10.1002/pros.24403. Epub 2022 Jul 5.

Jackson WC, Tang M, Schipper MJ, Sandler HM, Zumsteg ZS, Efstathiou JA, Shipley WU, Seiferheld W, Lukka HR, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Hall WA, Dess RT, Lovett RD, Balogh AG, Feng FY, Spratt DE. Biochemical Failure Is Not a Surrogate End Point for Overall Survival in Recurrent Prostate Cancer: Analysis of NRG Oncology/RTOG 9601. J Clin Oncol. 2022 Sep 20;40(27):3172-3179. doi: 10.1200/JCO.21.02741. Epub 2022 Jun 23.

Feng FY, Huang HC, Spratt DE, Zhao SG, Sandler HM, Simko JP, Davicioni E, Nguyen PL, Pollack A, Efstathiou JA, Dicker AP, Todorovic T, Margrave J, Liu YS, Dabbas B, Thompson DJS, Das R, Dignam JJ, Sweeney C, Attard G, Bahary JP, Lukka HR, Hall WA, Pisansky TM, Shah AB, Pugh SL, Shipley WU, Tran PT. Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):544-552. doi: 10.1001/jamaoncol.2020.7671. Erratum In: JAMA Oncol. 2021 Apr 1;7(4):639.

Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109.

• Responsible Party: Radiation Therapy Oncology Group
• ClinicalTrials.gov Identifier: NCT00002874
• Other Study ID Numbers: RTOG-9601; CDR0000065158; RTOG-R9601
• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Results First Submitted: June 6, 2017
• Results First Posted: August 18, 2017
• Last Update Posted: June 15, 2022