Adult Clinical Trials: GENITOURINARY & PROSTATE  


A Prospective Phase II Trial Of Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy  

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

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

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.  


T1-T2c, GS 2-6, PSA < 20 ng/mL
T1-T2c, GS 7, PSA < 10 ng/mL

>30 months after external radiotherapy
PSA < 10

Central pathology review confirmed

Prostate brachytherapy*


Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy

  • 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 > 0.1 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 9 or less;
  • No distant metastases, based upon the minimum diagnostic workup defined in the protocol;
  • AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
  • 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 ration;
  • No androgen deprivation therapy started after prostatectomy and prior to registration;
  • No prior pelvic radiotherapy

Arm 1: PBRT Alone*
PBRT 64.8-70.2 Gy 

PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before RT 

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


A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer  

  • Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma within 6 months prior to registration at intermediate risk for recurrence as determined by having one or more of the following intermediate-risk features: 
  • Gleason Score 7; PSA >10 but <20; Clinical Stage T2b-T2c. Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted in protocol Section 3.1.2.
  • No evidence of bone metastases (M0) on bone scan within 60 days 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, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration. Note: Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride.
  • CBC/differential obtained within 60 days prior to registration (for patients undergoing brachytherapy only), with adequate bone marrow function as defined in protocol Section 3.1.8. Patient must be able to provide study-specific informed consent prior to study entry.
  • No patients with all three intermediate risk factors who also have > 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
  • No prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted).
  • No prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer.
  • No prior hormonal therapy, such as LHRH agonists or bilateral orchiectomy.
  • No use of finasteride within 30 days prior to registration or use of dutasteride within 90 days prior to registration.
  • No prior or concurrent cytotoxic chemotherapy for prostate cancer.
  • No prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields.


Stratify by Number of Risk Factors; Comorbidity Status; RT Modality  

Arm 1:  Dose-escalated RT alone
Arm 2:  Dose-escalated RT combined with short-term (6 months) androgen blockade (LHRH agonist + antiandrogen)  

Androgen Deprivation Therapy and High Dose Radiotherapy with or without Whole-Pelvic Radiotherapy in unfavorable intermediate or favorable high risk Prostate Cancer: A Phase III Randomized Trial

Prostate Cancer diagnosis within 6 months prior to registration. Moderate to high risk with 1 or more of the following:

  • Gleason score 7-10 + T1c-T2b (palpation) + PSA <50
  • Gleason score 6 + T2c-T4 (palpation) +PSA<50 + 50% positive biopsies
  • Gleason score 6 + T1c-T2b (palpation) + PSA>20

CT or MRI of abd/pelvis within 90 days prior to registration
Bone scan within 120 days
Baseline PSA, (within 12 weeks) CMP and CBC within 14 days

Arm I: Neoadjuvant androgen deprivation therapy + prostate and seminal vesicle RT + boost to prostate and proximal seminal vesicles

Arm II: Neoadjuvant androgen deprivation therapy + whole-pelvic RT + boost to prostate and proximal seminal vesicles