|
| RTOG 0126 |
|---|
| Number: | RTOG 0126 |
| Title: |
A PHASE III RANDOMIZED STUDY OF HIGH DOSE 3D-CRT/IMRT VERSUS STANDARD DOSE 3D-CRT/IMRT IN PATIENTS TREATED FOR LOCALIZED PROSTATE CANCER |
| Eligibility: |
Histologically confirmed prostate adenocarcinoma within 180 days of randomization; Zubrod Performance Scale 0-1; Prostatic biopsy tumor grading by the Gleason Score Classification; One of the following combinations of factors:
- Clinical stage T1b-T2b, Gleason score 2-6, and prostate-specific antigen > 10 but < 20
- Clinical stage T1b-T2b, Gleason score 7, and prostate-specific antigen < 15
Clinically negative lymph nodes or histologically negative by nodal sampling or dissection, (NX, N0); No distant metastases (M0); No previous or concurrent invasive cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years; No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy; No previous or concurrent cytotoxic chemotherapy for this cancer; No previous hormonal treatment (no finasteride or phytoestrogen preparation within 3 months prior to registration); No radical surgery or cryosurgery for prostate cancer; Patients must sign study-specific informed consent form prior to randomization.
Only institutions that have met the technology requirements and that have provided the baseline physics information that are described in 3D-CRT Quality Assurance Guidelines (Appendix VI) or the IMRT Quality Assurance Guidelines (Appendix VII) may enter patients to this study. (For 3D-CRT only, institutions that have previously enrolled patients on RTOG 94-06 may enroll patients on this study without further credentialing.)
|
| TX: 3D-CRT/IMRT |
Arm 1 (minimum PTV prescription)
3D-CRT or IMRT: 70.2 Gy in 39 fractions
Arm 2 (minimum PTV prescription)
3D-CRT or IMRT: 79.2 Gy in 44 fractions
|
| Study size: | 1520 |
| RTOG 0232 |
|---|
| Number: | RTOG 0232 |
| Title: |
A Phase III Study Comparing Combined External Beam Radiation And Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma |
| Eligibility: |
Histologically confirmed, locally confined adenocarcinoma of the prostate; Clinical stages T1c-T2b; Zubrod 0-1; Age > 18 years; Combined Gleason 7 if PSA < 10, combined Gleason < 7 if PSA 10-20; PSA must be < 20ng/mL, before hormone therapy, if given (if Gleason 2-6, then PSA must be > 10 ng/mL; Prostate volume by TRUS < 60 cc; No prior chemotherapy, pelvic radiation, no prior TURP, cryosurgery, TUNA, TUMT or radical surgery for carcinoma of the prostate; No previous hormonal therapy beginning < 2 months or > 6 months prior to registration; No distant metastases, no clinically or pathologically involved lymph nodes; No significant obstructive symptoms; AUA must be < 15 (alpha blockers allowed); No hip prosthesis; No major medical or psychiatric illness; Study-specific informed consent form signed prior to study entry.
|
| RT |
Arm 1: 45 Gy EBRT, partial pelvis (1.8 Gy/fraction M-F for 5 weeks) followed 2-4 weeks later by Pd-103 (100 Gy) or I-125 (110 Gy)*
Arm 2: Pd-103 (125 Gy) or I-125 (145 Gy)*
*Protocol treatment must begin within 4 weeks after study entry.
|
| Study size: | 586 |
| RTOG 0415 |
|---|
| Number: | RTOG 0415 |
| Title: |
A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients With Favorable-Risk Prostate Cancer |
| Eligibility: |
Histologically confirmed prostate adenocarcinoma within 180 days of randomization. History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration. Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores will be divided into 2-4 (well differentiated) and 5-6 (moderately differentiated) for stratification/ Clinical stage T1-2c (AJCC 6th edition). PSA < 10 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics) The type of PSA assay (e.g., Abbott) should be recorded on the data forms. For those patients who used finasteride and are not excluded per Section 3.2.6, PSA should not be obtained until 30 days after stopping finasteride. For those patients who used dutasteride and are not excluded per Section 3.2.7, PSA should not be obtained until 90 days after stopping dutasteride. Zubrod performance status 0-1. Age > 18. Patient must sign study specific informed consent prior to randomization.
|
| Treatment: |
Arm 1 (Minimum PTV prescription)
3D-CRT or IMRT: 73.8 Gy in 41 fractions
Arm 2 (Minimum PTV prescription)
3D-CRT or IMRT: 70 Gy in 28 fractions
|
| Study size: | 1067 |
| RTOG 0521 |
|---|
| Number: | RTOG 0521 |
| Title: |
A Phase III Protocol of Androgen Suppression (AS) And 3DCRT/IMRT Vs AS and 3DCRT/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer |
| Eligibility: |
Histologically confirmed (within 180 days prior to registration) prostate cancer at high-risk for recurrence as determined by one of the following combinations:
| Gleason Score |
|
PSA |
|
T-Stage |
| > 9 |
and |
< 150 |
and |
Any |
| 8 |
and |
< 20 |
and |
> T2 |
| 7 |
and |
> 20-150 |
and |
Any |
Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR), nodal sampling, or dissection within 90 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 1.5 cm. Patients with positive lymph nodes by capromab pendetide (ProstaScint) scans are eligible provided a corresponding lymph node identified by CT or MR imaging is < 1.5 cm. No distant metastases, based upon the following minimum diagnostic work-up: History/physical examination (including weight) within 8 weeks prior to registration; Bone scan within 90 days prior to registration; Equivocal bone scan findings are allowed if plain films are negative for metastasis. Zubrod performance status 0-1. Age > 18. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3; Platelets > 100,000 cells/mm3; Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable). Pretreatment serum PSA, obtained prior to any LHRH or antiandrogen therapy. ALT, AST within 1.5X institutional upper normal limits; alkaline phosphatase within 2.5X institutional upper normal limits; and total bilirubin < institutional upper normal limits, obtained within 8 weeks prior to registration. Medical oncology consultation prior to registration. Prior 5-alpha reductase inhibitor (for example, finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration. Prior testosterone administration is allowed if last administered at least 90 days prior registration. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is < 50 days prior to the date of registration. Patient must sign study specific informed consent prior to study entry. Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
|
| Treatment: |
Arm 1
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.
Arm 2
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT.
PLUS
Six cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT:
Docetaxel i.v. over 1 hour (on day 1 of each cycle) q 21 days
(Premedication for docetaxel with dexamethasone is required)
AND
Prednisone p.o. daily until day 21 of the last cycle of chemotherapy
|
| Study size: | 600 |
| RTOG 0524 |
|---|
| Number: | RTOG 0524 |
| Title: |
A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer |
| Eligibility: |
Pathologically (histologically or cytologically) proven diagnosis of primary bladder transitional cell carcinoma with histologic evidence of muscularis propria invasion within 12 weeks of registration; Patients must be judged to be medically inappropriate for radical cystectomy; Patients must have undergone as thorough a TURB by a participating urologist as is judged safely possible. Bimanual examination by a participating urologist must have been performed, with tumor mapping as specified in Appendix V. (See Section 4.1.3); There must be sufficient tumor tissue available for her2/neu analysis; Based on the American Joint Committee on Cancer (AJCC), 6th edition (Appendix III): stage of transitional cell carcinoma (TCC) must be stages T2-T4a; Nx, N0 or N1; and M0; OR patients with primary bladder TCC grade 3/3 with AJCC clinical stage T1 who are felt to require definitive local therapy. Patients who have involvement of the prostatic urethra with TCC that was visibly completely resected, and have no evidence of stromal invasion of the prostate, remain eligible. They may not have evidence of distant metastases as determined by the following staging studies: Chest x-ray (or chest CT scan) within 8 weeks prior to registration, Abdominal/pelvic CT scan within 8 weeks prior to registration; History and physical examination including vital signs and body surface area within 4 weeks prior to registration; Zubrod performance status of < 2 (Appendix II); Age > 18; CBC/differential < 2 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) > 1,800 cells/mm3, Platelets > 100,000 cells/mm3, Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable); Adequate renal function, with serum creatinine < 3.0 mg/dl; Adequate liver function, with serum bilirubin < 2.0 mg/dl and SGOT/SGPT < 2.5 x the upper normal limit; EKG and either MUGA scan or echocardiogram within 8 weeks prior to study entry; Adequate left ventricular ejection fraction (EF) by either MUGA scan or echocardiogram, with minimum EF of 40%; Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy by the joint agreement of the participating radiation oncologist and medical oncologist; Protocol treatment should begin within 3 to 8 weeks following TURB; Patient must sign a study-specific informed consent prior to study entry; Negative pregnancy test for female patients of childbearing potential within 2 weeks prior to study entry; Women of childbearing potential and male participants must practice adequate contraception.
|
| Treatment: |
Group 1: Patients with her2/neu overexpression
Radiation Therapy
1.8 Gy qd for 5 fx/wk, for a total of 36 fx (1.8 Gy small pelvic fields x 22 fx, then reduction for 1.8 Gy x 8 fx, then 1.8 Gy boost x 6 fx for a total dose of 64.8 Gy)
Chemotherapy
Paclitaxel: d 1, 8, 15, 22, 29, 36, 43
Trastuzumab: d 1, 8, 15, 22, 29, 36, 43
Group 2: Patients without her2/neu overexpression
Radiation Therapy
1.8 Gy qd for 5 fx/wk, for a total of 36 fx (1.8 Gy small pelvic fields x 22 fx, then reduction for 1.8 Gy x 8 fx, then 1.8 Gy boost x 6 fx for a total dose of 64.8 Gy)
Chemotherapy
Paclitaxel: d 1, 8, 15, 22, 29, 36, 43
|
| Study size: | 88 |
| RTOG 0526 |
|---|
| Number: | RTOG 0526 |
| Title: |
A Prospective Phase II Trial Of Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
| Eligibility: |
Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion
of EBRT, biopsied 180 days prior to registration and confirmed by central pathology review;
Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit one of the following
categories (Appendix III):
- Stages T1-T2c, Gleason scores 2-6, and PSA 20 ng/mL, or
- Stages T1-T2c, Gleason score 7, and PSA 10 ng/mL
Staging, performed within 8 weeks prior to registration:
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
- Negative lymph nodes by imaging (pelvic abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
- No evidence of bone metastases (M0) on bone scan
Zubrod Performance Scale 0-1; International Prostate Symptom Score (IPSS) < 15; Age > 18; Baseline serum PSA value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy; Prostate volume as measured by transrectal ultrasound (TRUS) < 45 cc; Patient must be suitable for spinal or general anesthesia; No prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed;
No prior EBRT to the prostate that exceeded 72 Gy (2 Gy fractions) or 75.6 Gy (1.8 Gy fractions);
No baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) v3.0; No severe, active co-morbidity, defined as follows:
- Unstable angina and/or decompensated congestive heart failure
- Myocardial infarction within the last 6 months
- Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. Protocol-specific requirements may also exclude immuno-compromised patients.
No clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration); No histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1); None of the following prior therapies:
- Transurethral resection of the prostate (TURP)
- Radionuclide (permanent or temporary implantation) prostate brachytherapy
- Prostatectomy or prostatic cryosurgery
- HIFU (high-intensity focused ultrasound)
- Bilateral orchiectomy
- Chemotherapy for prostatic carcinoma
Patient must sign a study-specific informed consent form before study entry
NOTE 1: Androgen suppression therapy is permissible provided that the LHRH agonist was started at least 2 months and no more than 6 months before registration.
NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was < 8 months.
|
| Treatment: |
PRIOR TO EXTERNAL RADIOTHERAPY
T1-T2c, GS 2-6, PSA < 20 ng/mL
OR
T1-T2c, GS 7, PSA < 10 ng/mL
LOCAL RECURRENCE
>30 months after external radiotherapy
PSA < 10
STEP 1 REGISTER
Central pathology review confirmed
STEP 2 REGISTER
Prostate brachytherapy*
|
| Study size: | 96 |
| RTOG 0534 |
|---|
| Number: | RTOG 0534 |
| Title: |
A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy |
| Eligibility: |
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e., lymph node dissection is not required; Any type of radical prostatectomy will be permitted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted; Post-radical prostatectomy entry PSA of > 0.2 and < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration; One of the following pathologic classifications: T3N0/Nx disease or T2N0/Nx disease with positive prostatectomy margin and/or positive prostatic fossa or urethral-vesical anastomosis biopsies; Prostatectomy Gleason score of 8 or less; PSA doubling time of > 6 months prior to registration; Zubrod Performance Status of 0-1; Age > 18; Digital rectal exam within 30 days prior to registration; No distant metastases, based upon the minimum diagnostic workup defined in the protocol; Adequate bone marrow function, within 90 days prior to registration, defined as follows: Platelets > 100,000 cells/mm3 based upon CBC; Hemoglobin > 12.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb > 12.0 g/dl is acceptable). AST or ALT < 2 x the upper limit of normal within 90 days prior to registration; Serum total testosterone within 90 days prior to registration; patients must be able to provide study-specific informed consent prior to study entry.
No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer; N1 patients are ineligible, as are those with pelvic lymph node enlargement > 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative; No androgen deprivation therapy started prior to prostatectomy for > 6 months duration; No androgen deprivation therapy started after prostatectomy and prior to registration; No prior pelvic radiotherapy; No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible); Patients with PSA doubling time of < 6 months are ineligible; No severe, active co-morbidity, as defined in the protocol; No prior allergic reaction to the study drug(s) involved in this protocol.
|
| Treatment: |
Arm 1: PBRT Alone*
PBRT 64.8-70.2 Gy
Arm 2: PBRT + NC-STAD
PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before RT
Arm 3: PLNRT + PBRT + NC-STAD
PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months, beginning 2 months before RT
*SV = seminal vesicle; RT = radiotherapy; PBRT = prostate bed RT; PLNRT = pelvic lymph node RT; NC-STAD = neoadjuvant and concurrent short term androgen deprivation
|
| Study size: | 1764 |
| RTOG 0612 |
|---|
| Number: | RTOG 0612 |
| Title: |
Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study |
| Eligibility: |
Patient must be eligible for RTOG 0232. Patient must be enrolled on RTOG 0232. Submission of the paraffin tissue block from initial diagnosis. Submission of the biopsy specimen that contains frozen tissue. Patient must sign a study-specific informed consent for RTOG 0612 prior to study entry.
|
| Study size: | 96 |
| RTOG 0621 |
|---|
| Number: | RTOG 0621 |
| Title: |
Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial |
| Eligibility: |
Pathologically proven diagnosis of adenocarcinoma of the prostate gland at the time of prior radical prostatectomy meeting one of the following combinations:
- Pathologic Gleason > 7 and post-operative PSA nadir > 0.2 ng/ml with any pT classification;
- Pathologic Gleason > 8, post-operative PSA nadir < 0.2 ng/ml and > pT3a classification.
Enrollment must occur within 1 year from radical prostatectomy. Study entry PSA must be obtained within 6 weeks (42 days) prior to registration. Zubrod Performance Status 0-1; Age > 18; no lymph node or distant metastases (N0, M0), based upon the diagnostic workup specified in the protocol. Adequate bone marrow function as defined in the protocol. Testosterone obtained within 28 days prior to registration on study. Serum ALT, AST, alkaline phosphatase, bilirubin obtained within 28 days prior to registration on study. Evaluation and approval for study participation by a medical oncologist prior to registration. Patient must provide study-specific informed consent prior to study entry. No prior invasive malignancy unless disease free for a minimum of 3 years. No prior systemic chemotherapy for the study cancer. No prior androgen deprivation for treatment of prostate cancer. No prior use of hormonal agents such as finasteride or dutaseride for treatment of benign prostatic hypertrophy is allowed. No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. No severe, active co-morbidity as defined in the protocol. No prior allergic reaction to the study drug(s) involved in this protocol.
|
Androgen Suppression
And RT
And Docetaxel |
LHRH Agonist and Non-Steroidal Antiandrogen for 6 months
RT: 66.6 Gy/1.8 Gy/fraction, starting 8 weeks after initiation of androgen suppression
Docetaxel, starting 3-6 weeks after completion of radiation, Day 1 of each 21-day cycle x 6 cycles
|
| Study size: | 76 |
| RTOG 0622 |
|---|
| Number: | RTOG 0622 |
| Title: |
A PHASE II TRIAL OF SAMARIUM 153 FOLLOWED BY SALVAGE PROSTATIC FOSSA 3D-CRT OR IMRT IRRADIATION IN HIGH-RISK, CLINICALLY NON-METASTATIC PROSTATE CANCER AFTER RADICAL PROSTATECTOMY |
| Eligibility: |
Pathologically (histologically) proven diagnosis of prostate cancer progressing after radical prostatectomy as indicated by one of the following: Postoperative PSA rising above 2.0 ng/ml; or Postoperative PSA rising above 0.2 ng/ml with a surgical tumor Gleason score of 9 or 10; or Rapidly rising PSA profile with a doubling time less than 6 months. (PSA Doubling Time [PSADT] should be calculated via the Calculation of PSA Doubling Time page on the RTOG web site, http://www.rtog.org/psadt.html. Review the instructions for calculating the PSADT located at the top of this page and then select "Retrieve PSADT value" at the bottom center of the page.)
Pathologic stage T2 -T4 N0 - N1, with no distant metastases, based upon the following minimum diagnostic workup: History/physical examination within 8 weeks prior to registration; Bone scan negative for bone metastases within 4 months prior to registration; Abdominal imaging negative for metastases within 6 months prior to registration. Zubrod performance status 0-1. Age >18. CBC/differential and PSA obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute Neutrophil Count (ANC) >1,800 cells/mm3; Platelets >100,000 cells/mm3; Hemoglobin (Hgb) >8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >8.0 g/dl is permitted). Patient must be able to provide study specific informed consent prior to study entry.
|
| Treatment: |
Pre-local irradiation bone-targeted treatment with Samarium 153 as a single I.V. injection of 2.0 mCi/kg.
Evaluate for toxicity and PSA response at 12 weeks.
Prostatic Fossa 3D-CRT or IMRT Radiation Therapy (64.8 to 70.2 Gy).
Evaluate for toxicity and PSA response at 24 weeks.
If no response to prior therapy, then hormonal therapy.
|
| Study size: | 76 |
|
|
|
|
