Prostate Cancer, Sexual Dysfunction, Sexuality and Reproductive Issues
Conditions
Keywords
sexual dysfunction, sexuality and reproductive issues, adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction. PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.
Detailed description
OBJECTIVES: Primary * Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue. Secondary * Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens. OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs \> 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. * Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis. Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years Patients are followed at 3 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.
Interventions
RADIATIONradiation therapy
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1b-T2c by palpation * Pretreatment prostate-specific antigen ≤ 20 ng/mL * Gleason score ≤ 7 * Suitable erectile function, defined as a response ≥ score 2 in question #1 of the International Index of Erectile Function Questionnaire * No clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Fertile patients must use effective contraception * No other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months Radiotherapy * No prior pelvic radiotherapy Surgery * No prior or planned radical prostate surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction Rates | 5 year duration after completion of radiotherapy | Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Freedom From Biochemical Failure | 2 years after treatment | Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment. |
| Acute GI Toxicity | 5 years after treatment | — |
| Acute GU Toxicity | 5 years after treatment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| s-IMRT Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. | 54 |
| ETS-IMRT Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
radiation therapy: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. | 62 |
| Total | 116 |
Baseline characteristics
| Characteristic | ETS-IMRT | s-IMRT | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 61 years | 62 years |
| Race/Ethnicity, Customized Black | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 44 Participants | 95 Participants |
| Region of Enrollment United States | 62 participants | 54 participants | 116 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 62 Participants | 54 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 62 |
| other Total, other adverse events | 0 / 54 | 0 / 62 |
| serious Total, serious adverse events | 0 / 54 | 0 / 62 |
Outcome results
Primary
Erectile Dysfunction Rates
Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
Time frame: 5 year duration after completion of radiotherapy
Population: Some patients did not submit follow-up questionnaires at 24 months post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| s-IMRT | Erectile Dysfunction Rates | 27 Participants |
| ETS-IMRT | Erectile Dysfunction Rates | 36 Participants |
Secondary
Acute GI Toxicity
Time frame: 5 years after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| s-IMRT | Acute GI Toxicity | 1 Participants |
| ETS-IMRT | Acute GI Toxicity | 6 Participants |
Secondary
Acute GU Toxicity
Time frame: 5 years after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| s-IMRT | Acute GU Toxicity | 20 Participants |
| ETS-IMRT | Acute GU Toxicity | 27 Participants |
Secondary
Percentage of Patients With Freedom From Biochemical Failure
Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.
Time frame: 2 years after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| s-IMRT | Percentage of Patients With Freedom From Biochemical Failure | 90.7 percentage of participants |
| ETS-IMRT | Percentage of Patients With Freedom From Biochemical Failure | 91.8 percentage of participants |