Subjects must be receiving antiandrogen therapy (ADT) with a GnRH agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be < ng/dL at enrollment; subjects whose ADT is interrupted may enroll or continue on study as long as the testosterone is documented to remain < ng/dL for the entire duration of study participation; subjects who have undergone orchiectomy are also eligible
History of receiving more than classes of ADT
Non-castrate level of testosterone: >= ng/dL (prior androgen deprivation therapy [ADT] allowed; must be >= months since last dose of ADT)
Asymptomatic mCSPC patients with > % PSA decline after weeks of run in period with ADT, abiraterone plus prednisone
Prior ADT with GnRH analogue for prostate cancer for more than weeks
Started antiandrogen therapy (ADT) no longer than months prior to randomization
Received ADT for more than months prior to randomization
Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than weeks before randomization
Castrate levels of serum total testosterone (=< ng/dl) OR ongoing documented androgen deprivation therapy (ADT) unless pure small cell prostate cancer is present
Prior androgen deprivation therapy (ADT) in the past months; prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past months and testosterone has recovered (> ng/dl); the total duration of prior ADT should not exceed months
Castration resistant disease with confirmed testosterone level ? ng/ml under prior androgen deprivation therapy (ADT)
Patients on androgen deprivation therapy (ADT) are allowed
May have had up to months of ADT (testosterone suppression therapy) in the nonmetastatic setting and are at least months removed from treatment
No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
The use of androgen deprivation therapy (ADT) prior to registration or during radiation
Candidate for salvage radiation and ADT treatment
Post-prostatectomy use of ADT for > days prior to study entry (ADT defined as the use of a GnRH agonist, with or without an anti-androgen)
Indication to initiate androgen deprivation therapy (ADT)
AST/ALT > . X ULN or > X ULN in the presence of liver metastases; current treatment with anti-androgen is allowed for a maximum of one month to prevent flare response with antiandrogen therapy (ADT)
Current treatment with anti-androgen is allowed for a maximum of one month to prevent flare response with ADT
Patients may have received prior androgen deprivation therapy (ADT) - neoadjuvant and/or adjuvant setting only, but it must not have lasted for more than months (note that this is NOT the same as late induction as described in Section .b above); single or combination therapy allowed; at least months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting, and serum testosterone must be > ng/dL (non-castrate levels) within days prior to registration for early induction patients; Note: serum testosterone assessment is required for eligibility for only those with prior treatment with ADT
Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer; patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed)
No more than years of ADT is allowed, with the most recent ADT treatment having occurred greater than months prior to enrollment
Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:
Patients may have received prior androgen deprivation therapy (ADT) in the neoadjuvant, adjuvant and/or salvage setting, but must be off therapy for at least months and have a testosterone level > ng/dl
COHORT B: More than cycles of intermittent hormones (for the treatment of biochemical recurrence or castration sensitive metastatic disease), with a cycle defined as a period of consistent androgen deprivation therapy (generally - months) followed by intentional cessation of androgen deprivation therapy (ADT) without reinitiation of ADT until PSA rises
Subject must have failed at least one course of androgen deprivation therapy (ADT), i.e., treatment with GnRH analogues.
Other than ongoing ADT, prior treatment with other hormonal agents such as antiandrogens or ketoconazole must have been stopped at least two weeks prior to enrollment
Patients must be unresponsive to androgen-deprivation therapy (ADT), as indicated by a rising PSA level above the ADT nadir
Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) months prior to randomization
Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation therapy or prostatectomy for biochemically relapsed disease is allowed provided last dose of ADT is greater than (>) months prior to randomization and the Screening serum testosterone level is greater than or equal to (?) ng/dL
Prior ADT is allowed if it was an adjunct to definite local therapy, was given for =< year, and was completed at least months before initiating therapy for metastatic disease
Minimum PSA:\r\n* If no prior androgen deprivation therapy (ADT) for biochemical relapse:\r\n** . ng/mL if prior radical prostatectomy with or without adjuvant/salvage radiation therapy, confirmed by repeat measurement at least weeks later, or\r\n** Nadir + ng/mL if prior RT alone without prior radical prostatectomy, confirmed by repeat measurement at least weeks later\r\n* If prior ADT for biochemical relapse:\r\n** . ng/mL or > ng/mL above nadir on prior cycle of ADT, whichever is higher, confirmed by repeat measurement at least weeks later
Patients diagnosed with localized prostate cancer who are about to receive definitive treatment with either radiation with or without androgen deprivation therapy (ADT) or prostatectomy AND who also have a spouse or been in a committed relationship with their partner for at least months who is willing to participate in the study
A history of androgen deprivation therapy; patients receiving hormonal therapy in the adjuvant and/or neoadjuvant setting must have discontinued therapy at least months prior to day of treatment AND have a serum testosterone level >= ng/dL and cannot have received more than months of previous ADT
Previous androgen blockade (e.g. antiandrogens) given for greater than weeks in the last months; anti-androgens used during the initiation of ADT to avoid a flare phenomenon are acceptable for up to weeks
Appropriate for treatment with ADT in the opinion of the treating physician
Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the mans dosage is every six months and he has been off ADT for more than six he is eligible)
Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
Initiating ADT for prostate cancer prior to the previous months or are not on ADT holiday
Steroid hormone use (antiandrogen therapy [ADT]) within the past months
Diagnosed with prostate cancer\r\n* Treatment with ADT (gonadotropin-releasing hormone [GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer\r\n* Receiving ADT for a minimum of weeks before enrollment into the study\r\n* Planned ADT for the duration of the -week study period
Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment.
Initiating or within days of initiating ADT
Previously on ADT
CANCER PATIENT GROUP: Currently receiving ADT treatment for at least months (and continue to receive treatment during the duration of the study)
Expected duration of ADT at least months from date of study consent
Prior androgen deprivation therapy allowed, provided there is documented evidence of testosterone recovery to > ng/dL and greater than months duration between last effective date of ADT and date of study consent
Men ? years of age with non-metastatic prostate cancer, having undergone bilateral orchiectomy or initiated androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists and is expected to continue on ADT for at least months
PSADT > months and < months\r\n* Calculated based at least values that are post-treatment and > . in the prior years with the first and last PSA separated by at least months\r\n* Use all values in the last years that are post-treatment and > . to calculate PSADT\r\n* PSADT calculated while NOT on androgen deprivation therapy (ADT)\r\n* If prior ADT use, then documented either A) normal testosterone or B) a testosterone within points of normal and stable (defined as a second testosterone at least weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT
Androgen deprivation therapy (ADT) within months before Ga-PSMA- PET/CT.
Subjects receiving androgen deprivation therapy (ADT)
Not currently on ADT
Men who undergo neoadjuvant treatment with androgen deprivation therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded
Physician recommendation of ADT
Patients are deemed suitable for therapy with ADT and EBRT
Androgen deprivation therapy (ADT) in the past months
Subjects ADT naive or subjects who are already on ADT treatment and scheduled to receive radiation therapy for their adenocarcinoma of prostate are eligible. An -week course of ADT is required to be completed prior to NBTXR administration and initiation of radiation therapy .
For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs