Phase 3 N=1,532 Randomized Treatment

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00033631 ↗

Enrolled (actual)

1,532

Serious AEs

4.9%

Results posted

Feb 2017

Primary outcome: Primary: Overall Survival — 88.5; 88.1 percentage of participants — p=0.98

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 70.2 Gy 3D-CRT/IMRT (Radiation); 79.2 Gy 3D-CRT/IMRT (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Radiation Therapy Oncology Group
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	88.5; 88.1	0.98
SECONDARY Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition	40.2; 25.2	<0.0001 sig
SECONDARY Disease Specific Survival	1.4; 0.8	0.14
SECONDARY Local Progression	3.5; 1.8	0.0001 sig
SECONDARY Distant Metastases	3.1; 2.2	0.051
SECONDARY Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity	18.8; 21.0	0.29
SECONDARY Percentage of Participants With Erectile Disfuction at 12 Months	38.06; 49.66	0.0513
SECONDARY Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months	91; 91; 366; 331; 90; 95	0.59
SECONDARY Quality Adjusted Survival by SQLI	—	—
SECONDARY Tumor Control Probability	—	—
SECONDARY Normal Tissue Complication Probability	—	—

Summary

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. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
Clinical stage T1b-T2b
Meets one of the following criteria:
Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL
Gleason score 7 AND PSA < 15 ng/mL
No regional lymph node involvement
No distant metastases

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytotoxic chemotherapy
No concurrent cytotoxic chemotherapy

Endocrine therapy:

At least 3 months since prior finasteride
No other prior hormonal therapy, including:
Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
Antiandrogens (e.g., flutamide or bicalutamide)
Estrogens (e.g., diethylstilbestrol)
No concurrent (neoadjuvant or adjuvant) hormonal therapy

Radiotherapy:

No prior pelvic irradiation or brachytherapy

Surgery:

No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
No prior surgical castration (bilateral orchiectomy)

Other:

At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00033631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.